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NCT00006394 Clinical Trial

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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006394
Other study ID # 199/15433
Secondary ID UPSM-209300LILLY
Status Completed
Phase N/A
First received October 4, 2000
Last updated June 23, 2005
Start date April 1997

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 72
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Diagnosis of adult onset growth hormone deficiency

--Patient Characteristics--

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• growth hormone

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Case Western Reserve University Cleveland Ohio
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania
United States Oregon Health Sciences University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Mayo Clinic Rochester Minnesota
United States St. Louis University Health Sciences Center Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Pennsylvania

Country where clinical trial is conducted

United States, 

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