Osteoporosis Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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