|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by (Responsible Party): | Anne Klibanski, MD, 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:
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.
| Condition | Intervention |
|---|---|
|
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 |
| Enrollment: | 96 |
| Study Start Date: | August 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Somatropin
Stratified based on age, sex, and estrogen status: from 3 to 6 mcg/kg/day
Other Name: Genotropin
|
| Placebo Comparator: 2 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Anne Klibanski, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Anne Klibanski, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00182091 History of Changes |
| Other Study ID Numbers: | 2004p-001078 |
| Study First Received: | September 14, 2005 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Acromegaly Growth Hormone Deficiency Cardiovascular Risk Pituitary Hypothalamic |
|
Acromegaly Dwarfism, Pituitary Pituitary Diseases Endocrine System Diseases Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism 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 |