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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00182091 |
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 |
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Acromegaly Growth Hormone Deficiency Pituitary Disease |
Drug: Somatropin Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly |
Estimated Enrollment: | 160 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Somatropin
Stratified based on age, sex, and estrogen status: from 3 to 6 mcg/kg/day
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2: Placebo Comparator |
Drug: Placebo
Stratified based on age, sex, and estrogen status: from 3 to 6 mcg/kg/day
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Ages Eligible for Study: | 17 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lindsay E. Gunnell, BS | 617-724-1579 | lgunnell@partner.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Lindsay E Gunnell, BS 617-724-1579 lgunnell@partner.org | |
Contact: Tamara L. Wexler, MD 617-726-1347 twexler@partners.org | |
Principal Investigator: Anne Klibanski, MD |
Principal Investigator: | Anne Klibanski, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital / Harvard Medical School ( Anne Klibanski, MD ) |
Study ID Numbers: | 2004p-001078 |
Study First Received: | September 14, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00182091 |
Health Authority: | United States: Food and Drug Administration |
Acromegaly Growth Hormone Deficiency Cardiovascular Risk Pituitary Hypothalamic |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Endocrine System Diseases Central Nervous System Diseases Dwarfism, Pituitary |
Brain Diseases Bone Diseases Growth hormone deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy Acromegaly |
Hyperpituitarism Nervous System Diseases |