NCT00006394

Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	growth hormone

Timeline

• Start date: 1997-04-01
• First posted: 2000-10-05
• Last updated: 2005-06-24

Locations

7 sites across 1 country: United States