Acromegaly Medical Study Participation Opportunities

Acromegaly Clinical Trial Opportunities

ClinicalTrials.gov: Check this website to find out about medical trials in progress
http://www.mdanderson.org/patient-and-cancer-information/cancer-information/clinical-trials/index.html. (focuses mainly on cancer research)

Medical Studies

If your organization is looking to promote a medical study, please contact us to promote it.  Email us to have your study added.



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A Study Examining the Peri- and Post-operative Dynamics of the Growth Hormone (GH) - IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection
This study is currently recruiting participants.
Verified on December 2010 by Cedars-Sinai Medical Center

First Received on June 15, 2009.   Last Updated on December 14, 2010   History of Changes
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00921609
Purpose

Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a combination of these three treatments.

Subjects for this study will be recruited if they are:

  1. Adults, male or female, between the ages of 18-90.
  2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an MRI.
  3. Patients would have already agreed to have their acromegaly treated with surgery prior to study entry.

Subjects will have measurements of growth hormone using an oral glucose tolerance test (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but are being done to see if they relate more strongly to disease activity than IGF-I and growth hormone.

OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but are being done to examine the predictive ability of these tests at a very early time after surgery. Data obtained from these tests will be compared to the data gathered at the 1 year time point.

IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics, for clinical decision-making at the time of service. IGF-I and growth hormone will also be measured using other methods to attempt to investigate the variability of these hormones when different assays are used.


ConditionIntervention
Acromegaly
Other: OGTT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • The primary objective of this study will be to determine the natural course of acromegaly treated with surgery in subjects with non-suppressed GH nadir values and normal total IGF-I values. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A second objective of the study will be to determine the reliability of GH nadir to OGTT, free IGF-I, total IGF-I, and IGF binding proteins on post-operative day 1 in predicting long-term cure outcomes inacromegaly. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: October 2011
Groups/CohortsAssigned Interventions
Acromegaly peri- and post-op patients
All patients will undergo the same procedures throughout the study.
Intervention: Other: OGTT
Other: OGTT
An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.

Eligibility

Ages Eligible for Study: 18 Years to 90 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Enrollment will include subjects diagnosed with acromegaly caused by GH secreting adenomas who undergo surgical treatment for their disease provided they meet all inclusion/exclusion criteria.

Criteria

Inclusion Criteria:

  • Male or Female age 18-90
  • Diagnosed with acromegaly from a pituitary adenoma visualized by MRI, and with elevated IGF-1 levels compared to age and gender matched control values and nadir GH response to OGTT>1mg/L
  • Having already agreed to undergo surgical resection of their pituitary adenoma prior to study entry
  • Must provide informed consent

Exclusion Criteria:

  • Inability to complete the protocol due to intercurrent medical or psychiatric illness
  • Pregnant or breastfeeding
  • Use of insulin
  • Use of estrogen, progesterone, testosterone or thyroid hormone will be allowed as long as the dose is stable during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921609

Contacts
Contact: Lori Korsakoff, RN 310-423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Billy Gellepis 310-423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John Carmichael, MD Cedars-Sinai Medical Center
More Information

No publications provided 

Responsible Party: Cedars-Sinai Medical Center ( John Carmichael, MD / Attending Physician )
ClinicalTrials.gov Identifier: NCT00921609 History of Changes
Other Study ID Numbers: 8997
Study First Received: June 15, 2009
Last Updated: December 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
OGTT
post-op

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 12, 2011
 
Study of Heart Effects When Growth Hormone (GH) is Used for Growth Hormone Deficiency (GHD) Following Cure of Acromegaly (AcroGHD)
This study is currently recruiting participants.
Verified on February 2011 by Massachusetts General Hospital

First Received on February 18, 2011.   Last Updated on February 23, 2011   History of Changes
Sponsor: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302652
Purpose

Having too little or too much GH are both associated with heart disease.

The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. We will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).


ConditionIntervention
Acromegaly
Procedure: echocardiogram

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change from Baseline in Echocardiographic Findings at One Year [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/CohortsAssigned Interventions
AcroGHD on GH
Men and women with growth hormone deficiency following cure of acromegaly who are receiving growth hormone treatment.
Intervention: Procedure: echocardiogram
Procedure: echocardiogram
An echocardiogram will be performed in all subjects at baseline and at one year.
AcroGHD not on GH
Men and women with growth hormone deficiency following cure of acromegaly who are not receiving growth hormone treatment.
Intervention: Procedure: echocardiogram
Procedure: echocardiogram
An echocardiogram will be performed in all subjects at baseline and at one year.

Eligibility

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.

Criteria

Inclusion Criteria:

  • age 18-75
  • history of acromegaly with biochemical cure
  • growth hormone deficiency

Exclusion Criteria:

  • untreated thyroid disease within the past 3 months
  • untreated adrenal insufficiency within the past 3 months
  • uncontrolled hypertension
  • congestive heart failure
  • gonadal steroid therapy within the past 3 months
  • pregnancy or nursing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302652

Contacts
Contact: Eleanor Lin, MD 617-726-3897
Contact: Neuroendocrine Unit 617-726-3870

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eleanor Lin, MD     617-726-3870
Sub-Investigator: Eleanor Lin, MD
Principal Investigator: Karen K Miller, MD
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen K Miller, MD Massachusetts General Hospital
More Information

No publications provided 

Responsible Party: Neuroendocrine Unit, Massachusetts General Hospital ( Dr. Karen K. Miller )
ClinicalTrials.gov Identifier: NCT01302652 History of Changes
Other Study ID Numbers: 2010P002188
Study First Received: February 18, 2011
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acromegaly
growth hormone
growth hormone deficiency

Additional relevant MeSH terms:
Acromegaly
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dwarfism
Bone Diseases, Developmental
Hypopituitarism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 12, 2011
 

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The Treatment and Natural History of Acromegaly
This study is currently recruiting participants.
Verified on July 2010 by National Institutes of Health Clinical Center (CC)

First Received on January 21, 2000.   Last Updated on September 17, 2010   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001981
Purpose

The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.


Condition
Acromegaly
Pituitary Neoplasm

Study Type: Observational
Official Title: Acromegaly Treatment and Natural History

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: April 1985
Detailed Description:

The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
  • INCLUSION CRITERIA:

Patients will be enrolled who are 18 years of age or over who are referred for care.

More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001981 History of Changes
Other Study ID Numbers: 850082, 85-DK-0082
Study First Received: January 21, 2000
Last Updated: September 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Somatostatin Analogue
Acromegaly
TSH Producing Tumor
Islet Cell Tumor
Ursodeoxycholate
Pituitary
Irradiation
Treatment

Additional relevant MeSH terms:
Acromegaly
Neoplasms
Pituitary Neoplasms
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on June 12, 2011

 


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Ultrasound Guided Sandostatin LAR Injection in Acromegaly
This study is currently recruiting participants.
Verified on August 2010 by Cedars-Sinai Medical Center

First Received on October 31, 2007.   Last Updated on August 18, 2010   History of Changes
Sponsor: Cedars-Sinai Medical Center
Collaborator: Novartis Pharmaceuticals
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00552071
Purpose

The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.


ConditionIntervention
Acromegaly
Drug: Sandostatin LAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
1
3 months of ultrasound guided IM injections of octreotide LAR followed by 3 months of non-ultrasound guided injections of octreotide LAR
Interventions:
  • Drug: Sandostatin LAR
  • Drug: Sandostatin LAR
Drug: Sandostatin LAR
use of consistent monthly dose of medication for duration of 6 months.
Other Name: Ultrasound guided Sandostatin LAR injection
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
2
3 months of non-ultrasound guided octreotide LAR IM injections followed by ultrasound guided IM injections of LAR
Intervention: Drug: Sandostatin LAR
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.

Detailed Description:

IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Male and female patients ≥18 years old
  • Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
  • Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
  • Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
  • Patients have provided written informed consent

Exclusion Criteria:

  • Uncontrolled diabetes mellitus
  • Patients who are pregnant or lactating
  • Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
  • Patients with current gallstones
  • Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
  • Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
  • Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
  • Patients who have received other investigational drugs administered or received within 30 days of study entry
  • Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552071

Contacts
Contact: Billy Gellepis (310) 423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori Korsakoff, RN, BSN (310) 423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John D Carmichael, MD
Sub-Investigator: Shlomo Melmed, MD
Sub-Investigator: Vivien Bonert, MD
Sponsors and Collaborators
Cedars-Sinai Medical Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: John D Carmichael, MD Cedars-Sinai Medical Center
More Information

No publications provided 

Responsible Party: Cedars-Sinai Medical Center, Pituitary Center ( John Carmichael, MD )
ClinicalTrials.gov Identifier: NCT00552071 History of Changes
Other Study ID Numbers: 11482, CSMS995BUS60
Study First Received: October 31, 2007
Last Updated: August 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Octreotide LAR
Ultrasound guidance

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 12, 2011

ltrasound Guided Sandostatin LAR Injection in Acromegaly
This study is currently recruiting participants.
Verified on August 2010 by Cedars-Sinai Medical Center

First Received on October 31, 2007.   Last Updated on August 18, 2010   History of Changes
Sponsor: Cedars-Sinai Medical Center
Collaborator: Novartis Pharmaceuticals
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00552071
Purpose

The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.


ConditionIntervention
Acromegaly
Drug: Sandostatin LAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
1
3 months of ultrasound guided IM injections of octreotide LAR followed by 3 months of non-ultrasound guided injections of octreotide LAR
Interventions:
  • Drug: Sandostatin LAR
  • Drug: Sandostatin LAR
Drug: Sandostatin LAR
use of consistent monthly dose of medication for duration of 6 months.
Other Name: Ultrasound guided Sandostatin LAR injection
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
2
3 months of non-ultrasound guided octreotide LAR IM injections followed by ultrasound guided IM injections of LAR
Intervention: Drug: Sandostatin LAR
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.

Detailed Description:

IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Male and female patients ≥18 years old
  • Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
  • Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
  • Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
  • Patients have provided written informed consent

Exclusion Criteria:

  • Uncontrolled diabetes mellitus
  • Patients who are pregnant or lactating
  • Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
  • Patients with current gallstones
  • Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
  • Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
  • Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
  • Patients who have received other investigational drugs administered or received within 30 days of study entry
  • Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552071

Contacts
Contact: Billy Gellepis (310) 423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori Korsakoff, RN, BSN (310) 423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John D Carmichael, MD
Sub-Investigator: Shlomo Melmed, MD
Sub-Investigator: Vivien Bonert, MD
Sponsors and Collaborators
Cedars-Sinai Medical Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: John D Carmichael, MD Cedars-Sinai Medical Center
More Information

No publications provided 

Responsible Party: Cedars-Sinai Medical Center, Pituitary Center ( John Carmichael, MD )
ClinicalTrials.gov Identifier: NCT00552071 History of Changes
Other Study ID Numbers: 11482, CSMS995BUS60
Study First Received: October 31, 2007
Last Updated: August 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Octreotide LAR
Ultrasound guidance

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 12, 2011




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Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly (PAOLA)
This study is currently recruiting participants.
Verified on December 2010 by Novartis

First Received on May 27, 2010.   Last Updated on December 7, 2010   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT01137682
Purpose

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.


ConditionInterventionPhase
Acromegaly
Drug: Pasireotide (SOM230)
Drug: octreotide LAR 30mg or lanreotide ATG 120mg
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measure the tumor size reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: July 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Pasireotide LAR 40 mg: Experimental
Intervention: Drug: Pasireotide (SOM230)
Drug: Pasireotide (SOM230)
Pasireotide LAR 60 mg: Experimental
Intervention: Drug: Pasireotide (SOM230)
Drug: Pasireotide (SOM230)
Control arm (octreotide or lanreotide): Active Comparator
Intervention: Drug: octreotide LAR 30mg or lanreotide ATG 120mg
Drug: octreotide LAR 30mg or lanreotide ATG 120mg

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  1. Patients with written informed consent prior to any study related activity
  2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
  3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to randomization. The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg
  4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

  1. Patients who have received pasireotide (SOM 230) prior to enrolment
  2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to randomization (8 weeks wash out period)
  3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects
  4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
  5. Patients who have received pituitary irradiation within 10 years prior to randomization
  6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to randomization
  7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137682

Contacts
Contact: Novartis Pharmaceuticals +1 800-340-6843

Show 72 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

No publications provided 

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
ClinicalTrials.gov Identifier: NCT01137682 History of Changes
Other Study ID Numbers: CSOM230C2402, EUDRACT 2009-016722-13
Study First Received: May 27, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration;   Argentina: Ministry of Health;   Belgium: Ministry of Social Affairs, Public Health and the Environment;   Brazil: National Health Surveillance Agency;   Canada: Health Canada;   Colombia: Institutional Review Board;   France: Ministry of Health;   Germany: Ministry of Health;   Israel: Ministry of Health;   Italy: Ministry of Health;   Mexico: Ministry of Health;   Norway: Norwegian Medicines Agency;   Poland: Ministry of Health;   Romania: National Medicines Agency;   Russia: Ministry of Health and Social Development of the Russian Federation;   Saudi Arabia: Ministry of Health;   Spain: Ministry of Health and Consumption;   Turkey: Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Acromegaly
hormone disorder
growth hormone
insulin like growth factor-1
pituitary tumor

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Angiopeptin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 12, 2011
 
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Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly (PAOLA)
This study is currently recruiting participants.
Verified on December 2010 by Novartis

First Received on May 27, 2010.   Last Updated on December 7, 2010   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT01137682
Purpose

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.


ConditionInterventionPhase
Acromegaly
Drug: Pasireotide (SOM230)
Drug: octreotide LAR 30mg or lanreotide ATG 120mg
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measure the tumor size reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: July 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Pasireotide LAR 40 mg: Experimental
Intervention: Drug: Pasireotide (SOM230)
Drug: Pasireotide (SOM230)
Pasireotide LAR 60 mg: Experimental
Intervention: Drug: Pasireotide (SOM230)
Drug: Pasireotide (SOM230)
Control arm (octreotide or lanreotide): Active Comparator
Intervention: Drug: octreotide LAR 30mg or lanreotide ATG 120mg
Drug: octreotide LAR 30mg or lanreotide ATG 120mg

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  1. Patients with written informed consent prior to any study related activity
  2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
  3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to randomization. The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg
  4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

  1. Patients who have received pasireotide (SOM 230) prior to enrolment
  2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to randomization (8 weeks wash out period)
  3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects
  4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
  5. Patients who have received pituitary irradiation within 10 years prior to randomization
  6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to randomization
  7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137682

Contacts
Contact: Novartis Pharmaceuticals +1 800-340-6843

Show 72 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

No publications provided 

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
ClinicalTrials.gov Identifier: NCT01137682 History of Changes
Other Study ID Numbers: CSOM230C2402, EUDRACT 2009-016722-13
Study First Received: May 27, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration;   Argentina: Ministry of Health;   Belgium: Ministry of Social Affairs, Public Health and the Environment;   Brazil: National Health Surveillance Agency;   Canada: Health Canada;   Colombia: Institutional Review Board;   France: Ministry of Health;   Germany: Ministry of Health;   Israel: Ministry of Health;   Italy: Ministry of Health;   Mexico: Ministry of Health;   Norway: Norwegian Medicines Agency;   Poland: Ministry of Health;   Romania: National Medicines Agency;   Russia: Ministry of Health and Social Development of the Russian Federation;   Saudi Arabia: Ministry of Health;   Spain: Ministry of Health and Consumption;   Turkey: Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Acromegaly
hormone disorder
growth hormone
insulin like growth factor-1
pituitary tumor

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Angiopeptin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 12, 2011
 

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Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly
This study is currently recruiting participants.
Verified on February 2011 by Endo Pharmaceuticals

First Received on February 10, 2011.   No Changes Posted
Sponsor: Endo Pharmaceuticals
Information provided by: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01295060
Purpose

This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.


ConditionInterventionPhase
Acromegaly
Drug: Octreotide
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE IIIB, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF AN 84-MG OCTREOTIDE SUBCUTANEOUS HYDROGEL IMPLANT IN SUBJECTS WITHACROMEGALY

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Long term safety and tolerability of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ] [ Designated as safety issue: Yes ]
    Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site

Secondary Outcome Measures:
  • Evaluate the long term efficacy of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ] [ Designated as safety issue: No ]
    Patients will have GH and IGF-1 analyzed every 3 months

Estimated Enrollment: 18
Study Start Date: February 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Octreotide Implant: Experimental
Intervention: Drug: Octreotide
Drug: Octreotide
84 mg Octreotide Implant

Detailed Description:

Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Currently enrolled in the Extension Phase of Study IP107-001 and received at least one 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.
  • Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107 001.
  • In the opinion of the Investigator; subject has no unstable chronic medical conditions and no clinically significant findings that would preclude subject's participation in the study.
  • Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.

Exclusion Criteria:

  • Pituitary surgery less than 3 months prior to enrollment into this study
  • Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])
  • Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
  • Acute myocardial infarction within 3 months of Screening
  • Uncontrolled diabetes defined as having an HbA1c ≥9%
  • Symptomatic cholelithiasis
  • History of drug or alcohol abuse
  • Received any investigational drug or participated in another clinical trial except for study IP107 001 within 30 days of enrollment into this study
  • Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time prior to enrollment into this study
  • Receiving pegvisomant, dopamine agonist or other therapy in combination with somatostatin to control GH or IGF-1 levels prior to enrollment into this study
  • History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or, terminal systemic disease that limits life expectancy, or may interfere with the conduct of the study, or subjects who are incarcerated in penal institutions or are committed to mental institutions
  • Women who are pregnant or lactating. For females of childbearing potential, a positive pregnancy test prior to enrollment, or an unwillingness to use accepted forms of reliable birth control for study duration (including bilateral tubal ligation, use of oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
  • An unwillingness on the part of a male subject to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and spermicide and another form of contraception (eg, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295060

Contacts
Contact: Clinical Trial Manager This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, Colorado
Recruiting
Denver, Colorado, United States, 80220
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21215
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
United States, Washington
Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Endo Pharmaceuticals
More Information

No publications provided 

Responsible Party: Endo Pharmaceuticals Inc. ( Senior Director CR&D )
ClinicalTrials.gov Identifier: NCT01295060 History of Changes
Other Study ID Numbers: EN3332-301
Study First Received: February 10, 2011
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Acromegaly
Octreotide
IGF-1
Growth Hormone
Implant
Hydrogel

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 12, 2011
 
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Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
This study is currently recruiting participants.
Verified on May 2010 by Massachusetts General Hospital

First Received on September 14, 2005.   Last Updated on May 3, 2010   History of Changes
Sponsor: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182091
Purpose

The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels.

Acromegaly results when an area in the brain, called the pituitary, produces too much growth hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by treatment received.

We will study the effects of growth hormone replacement on the health of the heart and blood vessels of GH deficient persons by looking to see if this therapy:

  1. has effects on cardiovascular risk markers (special blood tests which indicate how healthy your heart and arteries are)
  2. affects the stiffness of the arteries
  3. affects your heart rate and the capacity of your heart to respond to changes in body position
  4. has different effects depending on whether you are taking estrogen / testosterone.

We will assess these measures of health on one occasion in persons with cured acromegaly and normal GH levels and in persons with cured acromegaly who have GH deficiency and a contraindication to receiving GH. GH deficient individuals with no contraindication to receiving GH, will participate in the study for 12 months. Individuals with normal GH levels, or who are GH deficient and have a contraindication to receiving GH, will be asked to return for one more visit.


ConditionIntervention
Acromegaly
Growth Hormone Deficiency
Pituitary Disease
Drug: Somatropin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • cardiovascular risk markers [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heart rate variability and arterial distensibility [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • effects of GH depending upon gonadal status [ Time Frame: baseline, 1, 3, 6, 7, 9, and 12 months ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
1: Active Comparator
Intervention: Drug: Somatropin
Drug: Somatropin
Stratified based on age, sex, and estrogen status: from 3 to 6 mcg/kg/day
Other Name: Genotropin
2: Placebo Comparator
Intervention: Drug: Placebo
Drug: Placebo
Stratified based on age, sex, and estrogen status: from 3 to 6 mcg/kg/day

Show Detailed Description
Eligibility

Ages Eligible for Study: 17 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Age 18-75
  • History of acromegaly with biochemical cure documented with a normal OGTT and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these
  • At the time of enrollment a minimum of 6 months must have elapsed since surgery.
  • No malignancy on colonoscopy performed since the diagnosis of acromegaly
  • GHD due to surgical or radiation treatment
  • GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GHRH plus arginine stimulation test
  • GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies

Exclusion Criteria:

  • Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
  • History of malignancy except for non-melanoma skin cancer
  • Hemoglobin <11.0 gm/dl
  • Uncontrolled hypertension
  • Hepatic or renal disease (AST/ALT > 3x ULN or creatinine level >2.5 mg/dl)
  • Congestive heart failure (New York Heart Association's classification system Class II-IV CHF will be excluded)
  • Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
  • Initiation or discontinuation of gonadal steroid therapy within 3 months of entry
  • Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance
  • Pregnancy or nursing
  • Active carpal tunnel syndrome
  • Subjects who have received GH therapy within one year prior to entry into the study
  • For female subjects age >40 a screening mammogram must have been obtained within one year prior to their baseline visit.
  • Sensitivity to m-cresol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182091

Contacts
Contact: Lindsay E. Gunnell, BS 617-724-1579 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lindsay E Gunnell, BS     617-724-1579      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Tamara L. Wexler, MD     617-726-1347      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Principal Investigator: Anne Klibanski, MD
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
More Information

Additional Information:
 
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Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
This study is currently recruiting participants.
Verified on July 2009 by Cedars-Sinai Medical Center

First Received on June 5, 2009.   Last Updated on July 28, 2009   History of Changes
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00915954
Purpose

Growth hormone (GH) and Insulin-like growth factor-I (IGF-I) secretion are altered in acromegaly and type 2 Diabetes Mellitis (DM). The secretion of GH is mediated by central hypothalamic hormones (GH Releasing Hormone and somatostatin) as well as peripheral factors providing feedback inhibition (IGF-I and glucose, among others). The purpose of this study is to compare growth hormone suppression after an oral glucose tolerance test (OGTT) to growth hormone suppression after recombinant human IGF-I (rhIGF-I) administration. This study will recruit participants with active acromegaly, type 2 diabetes mellitus, and healthy control subjects. Each participant will undergo a screening evaluation, and three subsequent visits. Each participant will receive a placebo subcutaneous injection, OGTT, and administration of rhIGF-I, on separate visit days. Glucose, insulin, GH, bioactive IGF-I and IGF-I binding proteins will be measured after each intervention. Results will be compared between the three groups. It is predicted that the administration of rhIGF-I will demonstrate GH suppression in all healthy subjects and subjects with type 2DM. Some acromegaly subjects may demonstrate GH suppression in response to IGF-I administration, but not to the degree seen in healthy subjects or type 2 DM. OGTT will demonstrate suppression of GH in normal subjects, and will show attenuated suppression in type 2 DM and a failure of suppression in acromegaly.


ConditionInterventionPhase
Acromegaly
Type 2 Diabetes Mellitus
Other: oral glucose tolerance test
Other: Subcutaneous administration of recombinant human IGF-1
Phase IV

Study Type: Interventional
Study Design: Masking: Single Blind (Subject)
Official Title: Growth Hormone Feedback In Patients With Acromegaly, Type 2 Diabetes Mellitus, And Healthy Adults

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Growth hormone nadir, defined as the lowest measured growth hormone after administration of a suppressive agent (oral glucose or rhIGF-I) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in IGFBP-1, insulin, glucose, bioactive IGF-I after administration of placebo, OGTT and rhIGF-I [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Intervention Details:
    Other: oral glucose tolerance test
    Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
    Other: Subcutaneous administration of recombinant human IGF-1
    Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

  • Active acromegaly due to excess GH produced by a pituitary adenoma.
  • Patients must have an elevated IGF-I compared to age and gender matched controls (as supplied by the laboratory) and fail to suppress GH to below 1 ng/ml after a standard 75g oral glucose tolerance test.
  • Type 2 diabetes mellitus, defined by elevated fasting glucose ≥ 126 mg/dl (verified by two historical measurements), or plasma glucose ≥ 200 mg/dl two hours after a 75 g oral glucose load, or a random glucose ≥ 200 mg/dl.

Exclusion Criteria:

  1. Acromegaly Group

    • Current medical therapy for acromegaly including dopamine agonists, somatostatin analogues, or growth hormone antagonists.
    • For subjects on current therapy the following washout periods may be used:

      • Cabergoline: 4 weeks
      • Bromocriptine: 1 week
      • Sandostatin LAR: 3 months
      • Short-acting octreotide: 1 week
      • Lanreotide: 3 months
      • Pegvisomant: 4 weeks
    • Subjects with a history of surgical therapy for treatment of acromegaly must have verification of active disease with verified elevated IGF-I for the subjects' age and gender compared to healthy controls (as supplied by the laboratory) (two measures) as well as a failure to suppress GH to below 1 ng/ml after OGTT.
    • Current treatment for insulin resistance or type 2 DM including oral or injection medications.
    • Fasting glucose ≥ 126 mg/dl at screening evaluation.
    • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
    • Pregnancy or breast feeding.
  2. Type 2 diabetes mellitus group

    • Patients taking non-insulin medications for diabetes treatment will be excluded.
    • Diagnosis of acromegaly.
    • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
    • Pregnancy or breast feeding.
  3. Healthy Control Group

    • History of diabetes mellitus or impaired glucose tolerance, history of acromegaly.
    • Fasting glucose ≥ 126 mg/dl at screening evaluation.
    • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
    • Pregnancy or breast feeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915954

Contacts
Contact: William Gellepis 310-423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori Korsakoff, RN 310-423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John Carmichael, MD
Sponsors and Collaborators
Cedars-Sinai Medical Center
More Information

No publications provided 

ClinicalTrials.gov Identifier: NCT00915954 History of Changes
Other Study ID Numbers: 17015
Study First Received: June 5, 2009
Last Updated: July 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Type 2 diabetes mellitus
recombinant human IGF1
oral glucose tolerance test

Additional relevant MeSH terms:
Acromegaly
Diabetes Mellitus
Diabetes Mellitus, Type 2
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 12, 2011
 
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Oral Glucose Tolerance Testing (OGTT) on Patients Taking Somatostatin Analogs
This study is currently recruiting participants.
Verified on June 2011 by Cedars-Sinai Medical Center

First Received on June 9, 2011.   No Changes Posted
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01371045
Purpose

The purpose of this study is to test the effect of long-acting somatostatin analog medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in comparison to healthy controls who are not receiving the medication in order to see whether or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of the medication and the underlying disease state can be analyzed.


ConditionIntervention
Acromegaly
Other: Oral Glucose Tolerance Test (OGTT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Growth hormone response to OGTT [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects

Biospecimen Retention:   Samples With DNA

Blood will be drawn (approx. 64cc) to gather baseline hormone and metabolic panels. Blood will again be collected (approx. 36cc) during the Oral Glucose Tolerance Test.


Estimated Enrollment: 36
Study Start Date: June 2011
Groups/CohortsAssigned Interventions
Acromegaly
Patients carrying the diagnosis of acromegaly who are on long-acting somatostatin for at least 3 months prior to study enrollment.
Intervention: Other: Oral Glucose Tolerance Test (OGTT)
Other: Oral Glucose Tolerance Test (OGTT)
An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
Carcinoid Syndrome
Patients carrying a diagnosis of carcinoid syndrome who are taking long-acting somatostatin for at least 3 months prior to study enrollment.
Intervention: Other: Oral Glucose Tolerance Test (OGTT)
Other: Oral Glucose Tolerance Test (OGTT)
An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
Healthy Controls
Intervention: Other: Oral Glucose Tolerance Test (OGTT)
Other: Oral Glucose Tolerance Test (OGTT)
An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.

Detailed Description:

Subjects will be informed of the study and after providing written informed consent, subjects will be asked to undergo a 2-hour oral glucose tolerance test (ingestion of 75g glucose with subsequent timed assessment of growth hormone, glucose, insulin and related binding proteins.) Baseline assessment of hormones that may contribute to the results will be drawn, prior to performing the test. Patients will be asked to complete one visit total to participate in this trial.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population

Enrollment will include subjects diagnosed with acromegaly or carcinoid syndrome who are taking long-acting somatostatin analogs for at least three months prior to study enrollment.

Criteria

Inclusion Criteria:

  • Diagnosis of acromegaly or carcinoid syndrome
  • Treatment with somatostatin analog therapy (must have established a stable dose of three or more injections on the same dose prior to study enrollment)
  • Healthy control subjects

Exclusion Criteria:

  • Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
  • Use of medication for the treatment of insulin resistance or diabetes
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371045

Contacts
Contact: Hershel Bhadsavle (310) 423-2830 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Billy Gellepis 310-423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John Carmichael, M.D.
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John D Carmichael, M.D. Cedars-Sinai Medical Center


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Tissue Biomarker for Pegvisomant Action
This study is currently recruiting participants.
Verified on December 2010 by Cedars-Sinai Medical Center

First Received on December 15, 2010.   No Changes Posted
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01261000
Purpose

Acromegaly is a disease of the pituitary gland that involves the overproduction of growth hormone. The drug works by blocking the binding of growth hormone to growth hormone receptors found in tissues throughout the body. Human studies have evaluated the reduction of IGF-I levels in the blood following pegvisomant treatment, however, no studies have evaluated IGF-I levels in tissues following pegvisomant administration. In this study, we will test a novel tissue biomarker for pegvisomant action, distinct from measuring IGF-I levels in the blood. To this end, we will determine if administration of pegvisomant modifies the expression of IGF-I, IGF-I receptor, growth hormone receptor and GH- and IGF-i-dependent signaling molecules in the colon tissue of patients with acromegaly.


ConditionIntervention
Acromegaly
Drug: Pegvisomant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tissue Biomarker for Pegvisomant Action

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Develop a tissue biomarker for pegvisomant action, other than serum IGF-I [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Pegvisomant: Experimental
Intervention: Drug: Pegvisomant
Drug: Pegvisomant
Pegvisomant used as indicated
Other Name: Somavert

Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • The subject has provided written informed consent prior to any study related procedure
  • The patient age is between 18 and 80 years inclusive
  • The patient is male or female. If the woman is at risk of becoming pregnant, she must agree to use an effective method of contraception including implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261000

Contacts
Contact: Billy Gellepis 310-423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori Korsakoff, RN 310-423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Shlomo Melmed, MD
Sub-Investigator: Magdalena Uhart, MD
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
More Information

No publications provided 

Responsible Party: Cedars-Sinai Medical Center ( Shlomo Melmed, MD )
ClinicalTrials.gov Identifier: NCT01261000 History of Changes
Other Study ID Numbers: 23051, WS921563
Study First Received: December 15, 2010
Last Updated: December 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 12, 2011
  
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Genetics of Endocrine Tumours
This study is currently recruiting participants.
Verified on April 2007 by Barts & The London NHS Trust

First Received on April 16, 2007.   Last Updated on July 26, 2010   History of Changes
Sponsor: Barts & The London NHS Trust
Information provided by: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00461188
Purpose

The research is aimed at identifying new predisposition genes for endocrine tumours. Our focus initially is on somatotrophinomas and prolactinomas, but we wish to extend work to other pituitary tumour cases/families.

The recruitment process will be as follows.

  1. We will recruit patients from our own Endocrine outpatient clinics and inpatient wards. In addition we will ask colleagues in other Endocrinology Departments (or other specialties such as Clinical Genetics, Pathology, General Medicine ) to identify potentially suitable patients with endocrine & pituitary tumours from their records. We shall focus on patients with good evidence of inheritance of their condition: relatively early onset; or multiple lesions; or other affected family members. Conditions where the predisposing genes have been identified (principally MEN) will be excluded from study.
  2. The Consultant looking after the patient will contact the patient to initially inform him/her of the study.
  3. We will then contact the patient (generally by telephone) to discuss the study and what it would entail in terms of information and samples.
  4. Subject to agreement in (3), patient will receive 'Information Sheet for patients with pituitary tumour' and 'Consent Form' and will have blood sampling in Consultant's clinic.
  5. We will contact additional family members (if appropriate) after an initial approach by the family member already recruited to the study. The additional family members may have developed tumours similar to those of the proband, or may be unaffected individuals who provide useful information for gene identification purposes (for example, spouses may greatly aid the power of gene mapping by linkage. They will receive the "Information Sheet for family members". analysis).

8. Archival tissue will be obtained from HTA licensed tissue banks. This is an established bank whose licence is primarily for diagnosis but can be used for research. 9. We will undertake laboratory work, such as genetic linkage analysis, candidate gene mutation screening and studies of loss of heterozygosity in tumours, to identify the genes predisposing to the condition, such as the AIP gene. In addition we would like to screen other genes related to the chaperon AIP molecule, such as AhR, and other genes currently identified (PDE4A5, survivin and Tom20 protein) or may not been identified.

Blood samples for DNA and RNA will coded with unique ID numbers. Pituitary and other endocrine tumour samples will be collected at surgery and kept in liquid nitrogen or −80 C. They will be coded with unique ID numbers. Candidate gene sequencing will be performed in the Barts and the London Medical School Genome Centre.

RNA expression studies from blood or adenoma tissue samples will be performed by RT−PCR. Protein expression studies will be performed by Western blotting or immunohistochemistry. The first gene we wish to study causes familial acromegaly, a disease resulting from a pituitary adenoma secreting growth hormone.

To establish if the candidate gene is also causing possibly sporadic (not familial) cases of the disease, samples (blood and tissue) will be collected from patients with sporadic disease and will be analysed as above.


Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetics of Endocrine Tumours

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Biospecimen Retention:   Samples With DNA

DNA sample, tissue sample


Estimated Enrollment: 150
Study Start Date: March 2007
Estimated Study Completion Date: April 2017
Show Detailed Description
Eligibility

Ages Eligible for Study: 6 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

pituitary disease patients

Criteria

Inclusion Criteria:

  • Familial acromegaly or other type of pituitary tumour OR
  • Early onset acromegaly or
  • Sporadic pituitary tumour

Exclusion Criteria:

  • Do not consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461188

Contacts
Contact: Marta Korbonits, MD PhD 020 7882 6238 ext 6238 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United Kingdom
Barts and the London medical School Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Marta Korbonits, MD PhD          This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Royal Victoria Infirmary Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Contact: Richard Quinton, MD FRCP     0191 282 4635      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Marta Korbonits, MD PhD Barts and the London Medical School
More Information

No publications provided 

Responsible Party: R&D Barts and the London School of Medicine / NHS Trust ( Gerry Leonard )
ClinicalTrials.gov Identifier: NCT00461188 History of Changes
Other Study ID Numbers: 004842
Study First Received: April 16, 2007
Last Updated: July 26, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Barts & The London NHS Trust:
acromegaly
familial pituitary adenoma

Additional relevant MeSH terms:
Acromegaly
Endocrine Gland Neoplasms
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 12, 2011
 

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Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma (PRIMARYS)
This study is currently recruiting participants.
Verified on May 2011 by Ipsen

First Received on June 3, 2008.   Last Updated on May 17, 2011   History of Changes
Sponsor: Ipsen
Information provided by: Ipsen
ClinicalTrials.gov Identifier: NCT00690898
Purpose

Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and IGF-1 levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.


ConditionInterventionPhase
Acromegaly
Drug: Lanreotide autogel 120 mg
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • The primary efficacy endpoint will be the percentage of patients achieving reduction in tumor volume at V5 (at Week 48) in comparison to baseline (as measured by MRI) [ Time Frame: From W1 (baseline) to W48. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of serum IGF-1 level and serum GH levels [ Time Frame: At W1, 12, 24 & 48 ] [ Designated as safety issue: No ]
  • Changes of prolactin level in patients with initially increased prolactin level (at screening) [ Time Frame: At each assessment (W12, 24 & 48). ] [ Designated as safety issue: No ]
  • Change of clinical signs of acromegaly [ Time Frame: At each assessment visit at W12,24 &48 ] [ Designated as safety issue: Yes ]
  • Changes in the quality of life assessment [ Time Frame: At each assessment visit at W12, 24 & 48 ] [ Designated as safety issue: No ]
  • Adverse events and local tolerability information [ Time Frame: Recorded at any time during the study ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
  • Physical examination findings [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
  • Gallbladder ultrasound [ Time Frame: Assessed at screening and W48 ] [ Designated as safety issue: Yes ]
  • Laboratory tests: standard haematology and biochemistry analyses [ Time Frame: At W1 and W48 ] [ Designated as safety issue: Yes ]
  • Glucose tolerance based on fasting blood glucose [ Time Frame: At W12, 24 & 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: May 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Lanreotide autogel 120 mg: Experimental
Intervention: Drug: Lanreotide autogel 120 mg
Drug: Lanreotide autogel 120 mg
12 months

Eligibility

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • The patient has given written informed consent prior to any study related procedures
  • The patient is male or female and is aged between 18 and 75 years, inclusive,
  • Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results),
  • The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading,
  • The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement:

    • Not related to the pituitary adenoma
    • Clinically stable condition not presumed to change during the study period
    • Not modifying the ability to evaluate visual field changes related to the macroadenoma

Exclusion Criteria:

  • The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure,
  • The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study,
  • The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol,
  • The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
  • The patient is pregnant or lactating,
  • The patient has a history of, or known current, problems with alcohol abuse,
  • The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
  • The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study,
  • The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry,
  • The patient has previously been treated with a somatostatin analogue,
  • The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry,
  • The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period,
  • Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central laboratory results),
  • Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),
  • Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.
More Information

No publications provided 

Responsible Party: Ipsen ( Antoine Clermont )
ClinicalTrials.gov Identifier: NCT00690898 History of Changes
Other Study ID Numbers: 2-79-52030-207
Study First Received: June 3, 2008
Last Updated: May 17, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products;   France: Afssaps - French Health Products Safety Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Germany: Ministry of Health;   Sweden: Medical Products Agency;   Czech Republic: State Institute for Drug Control;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Finland: Finnish Medicines Agency;   Turkey: Ministry of Health;   Spain: Spanish Agency of Medicines;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 12, 2011
 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
This study is currently recruiting participants.
Verified on January 2011 by University of Aarhus

First Received on March 26, 2008.   Last Updated on January 7, 2011   History of Changes
Sponsor: University of Aarhus
Collaborator: Aarhus University Hospital
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647179
Purpose

The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.


ConditionIntervention
Acromegaly
Growth Hormone
Insulin Resistance
Procedure: Transsphenoidal adenomectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood, serum, muscle samples, fat samples


Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/CohortsAssigned Interventions
1
Patients recently diagnosed with acromegaly
Intervention: Procedure: Transsphenoidal adenomectomy
Procedure: Transsphenoidal adenomectomy
Surgery

Eligibility

Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Patiens recently diagnoses with acromegaly, recruited from the clinic

Criteria

Inclusion Criteria:

  • Written consent
  • Age between 18 and 70
  • Recently diagnosed with acromegaly

Exclusion Criteria:

  • NYHA 3
  • Uncontrolled hypertension
  • Known cerebrovascular disease
  • Proliferative retinopatia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647179

Contacts
Contact: Jens Otto L. Jørgensen, Professor MD 89492025 ext +45 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Michael Madsen, MD 89492171 ext +45 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus C, Aarhus, Denmark, DK-8000
Principal Investigator: Jens Otto L. Jørgesen, Professor MD
Sub-Investigator: Michael Madsen, MD
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jens Otto L. Jørgensen, Professor MD Aarhus University Hospital, Department of Endocrinology
More Information

No publications provided 

Responsible Party: Aarhus University Hospital ( Jens Otto Lunde Jørgensen )
ClinicalTrials.gov Identifier: NCT00647179 History of Changes
Other Study ID Numbers: MM-ISA-20070130, M-20070130
Study First Received: March 26, 2008
Last Updated: January 7, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics;   Denmark: The Regional Committee on Biomedical Research Ethics;   Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Acromegaly
Growth Hormone
Insulin resistance
Glucose tolerance
Body Composition
Substrate metabolism

Additional relevant MeSH terms:
Acromegaly
Insulin Resistance
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 12, 2011
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The Observational Study of Growth Hormone-secreting Pituitary Tumors
This study is currently recruiting participants.
Verified on June 2011 by Huashan Hospital

First Received on June 6, 2011.   No Changes Posted
Sponsor: Huashan Hospital
Collaborator: National Natural Science Foundation of China
Information provided by: Huashan Hospital
ClinicalTrials.gov Identifier: NCT01368133
Purpose

The major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis.


Condition
Acromegaly
Pituitary Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Observational Study of the Structures and Functions of Multiple Organs in Patients With Growth Hormone-secreting Tumors

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Biospecimen Retention:   Samples With DNA

Plasma, DNA and pituitary tumor tissues


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Multiple organs or systems will be affected by excessive growth hormones in patients with acromegaly. The major purpose of this study is to evaluate the changes before and after the pituitary surgery.

Eligibility

Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample
Study Population

The acromegaly patients at Huashan Hospital will be recruited anf followed up prior to surgery and one month, 3 months and 6 months after surgery.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of acromegaly
  • > 18 years old
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368133

Contacts
Contact: Jiahui Qiu, M.D. 86-13585951850 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: zhaoyun zhang, M.D. 86-21-52888286 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
China
Huashan Hospital Recruiting
Shanghai, China, 200040
Contact: Cuiyun Wu     86-21-52888047      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Zhaoyun Zhang     86-21-52888286      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Principal Investigator: Yao Zhao, M.D.
Sponsors and Collaborators
Huashan Hospital
National Natural Science Foundation of China
Investigators
Principal Investigator: Yao Zhao, M.D. Huashan Hospital
More Information

No publications provided 

Responsible Party: Huashan Hospital ( Yao Zhao )
ClinicalTrials.gov Identifier: NCT01368133 History of Changes
Other Study ID Numbers: 2010M-010
Study First Received: June 6, 2011
Last Updated: June 6, 2011
Health Authority: China: State Food and Drug Administration

Keywords provided by Huashan Hospital:
acromegaly
pituitary tumor

Additional relevant MeSH terms:
Acromegaly
Pituitary Neoplasms
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 12, 2011
 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (LEAD)
This study is currently recruiting participants.
Verified on May 2011 by Ipsen

First Received on June 18, 2008.   Last Updated on May 17, 2011   History of Changes
Sponsor: Ipsen
Information provided by: Ipsen
ClinicalTrials.gov Identifier: NCT00701363
Purpose

The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg


ConditionInterventionPhase
Acromegaly
Drug: Lanreotide Autogel 120 mg
Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of subjects having maintained their injection interval schedule of six weeks or increased their injection interval to eight weeks whilst keeping their normalised IGF 1 levels (age and sex adjusted) [ Time Frame: At study end at Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with normalised IGF 1 levels (age and sex adjusted) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects having maintained an injection interval of six weeks or increasing their injection interval to eight weeks [ Time Frame: During Phase 2 of the study ] [ Designated as safety issue: No ]
  • Mean change from baseline in IGF 1 values (expressed as % of ULN) overall and by injection interval [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Maintain normalised IGF 1 values [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Symptoms of acromegaly (headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia) [ Time Frame: At baseline, Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Mean changes from baseline in Quality of Life scores (AcroQoL* and SF 36) [ Time Frame: At Week 24 and Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 127
Study Start Date: October 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Lanreotide Autogel 120 mg: Experimental
Intervention: Drug: Lanreotide Autogel 120 mg
Drug: Lanreotide Autogel 120 mg
120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • The subject has given written informed consent prior to any study-related procedures
  • The subject is male or female and is over 18 years of age
  • The subject must have had documentation supporting the diagnosis of acromegaly
  • The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
  • If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period

Exclusion Criteria:

  • The subject has received radiation therapy to the pituitary gland before study entry
  • The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
  • The subject has received a GH receptor antagonist (pegvisomant) therapy within three months before study entry
  • The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
  • The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study
More Information

No publications provided 

Responsible Party: Ipsen ( Stefan Lempereur )
ClinicalTrials.gov Identifier: NCT00701363 History of Changes
Other Study ID Numbers: A-38-52030-214, 2007-005838-37
Study First Received: June 18, 2008
Last Updated: May 17, 2011
Health Authority: Sweden: Medical Products Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Denmark: Danish Medicines Agency;   Finland: Finnish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Latvia: State Agency of Medicines;   South Korea: Korea Food and Drug Administration (KFDA);   Russia: Ministry of Health and Social Development of the Russian Federation;   Greece: National Organization of Medicines;   Brazil: Ministry of Health;   Norway: Norwegian Medicines Agency;   Serbia: Ministry of Health;   Poland: Ministry of Health

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 12, 2011
 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma
This study is currently recruiting participants.
Verified on December 2010 by Cedars-Sinai Medical Center

First Received on January 11, 2008.   Last Updated on December 14, 2010   History of Changes
Sponsor: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00598949
Purpose

The purpose of the study is to determine genetic links among blood-relatives and between spouses of patients with pituitary tumors.


Condition
Pituitary Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Biospecimen Retention:   Samples With DNA

cell lines are established for future genetic analysis


Estimated Enrollment: 600
Study Start Date: January 2003
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of the family study is to investigate the genetic basis for the development of pituitary tumors by assessing the prevalence of pituitary tumors in relatives of probands with the disease as compared to the prevalence in unrelated spouses sharing a similar environment.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

tertiary referral center

Criteria

Inclusion Criteria:

  • patients harboring secretory or non-secretory adenomas and/or siblings and/or spouses

Exclusion Criteria:

  • patient without consenting siblings and/or siblings and/or spouses
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598949

Contacts
Contact: Billy Gellepis 310-423-3395 This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori korsakoff, RN 310-423-2411 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Locations
United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Contact: Vivien Bonert, MD     310-423-2830      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Contact: Lori Korsakoff, RN     310-423-2411      This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Vivian Bonert, MD Cedars-Sinai Medical Center
More Information

No publications provided 

Responsible Party: Cedars-Sinai Medical Center, Pituitary Center ( Vivien Bonert, MD )
ClinicalTrials.gov Identifier: NCT00598949 History of Changes
Other Study ID Numbers: 3765, 3765
Study First Received: January 11, 2008
Last Updated: December 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Pituitary
Adenoma
Tumor
Acromegaly
Prolactinoma
Cushing's

Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 12, 2011
 

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