Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
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Purpose
OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.
II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH.
III. Compare the quality of life of these patients treated with these 2 regimens.
IV. Determine the side effects of GH in these patients.
| Condition | Intervention |
|---|---|
|
Osteoporosis Growth Hormone Deficiency |
Drug: growth hormone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 72 |
| Study Start Date: | April 1997 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 2 years. Arm II: Patients receive placebo SC daily for 2 years. Quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of adult onset growth hormone deficiency
--Patient Characteristics--
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114-2617 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| United States, Ohio | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| University of Pennsylvania School of Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Study Chair: | Peter Snyder | University of Pennsylvania |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006394 History of Changes |
| Other Study ID Numbers: | 199/15433, UPSM-209300, LILLY-B9R-US-GDEO |
| Study First Received: | October 4, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Research Resources (NCRR):
|
disease-related problem/condition endocrine disorders growth hormone deficiency |
osteoporosis quality of life rare disease |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Osteoporosis Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Bone Diseases, Metabolic Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013