Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114-2617|
|United States, Minnesota|
|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|