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

National Center for Research Resources (NCRR)

Status

Completed

Conditions

Osteoporosis

Growth Hormone Deficiency

Treatments

Drug: growth hormone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00006394

199/15433

LILLY-B9R-US-GDEO

UPSM-209300

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--