Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
- Conditions
- OsteoporosisGrowth Hormone Deficiency
- Registration Number
- NCT00006394
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Pennsylvania School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States