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

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006394

Collaborator

University of Pennsylvania (Other)

Enrollment

Locations

10.3

Patients Per Site

Study Details

Study Description

Brief 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.

Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH.
Compare the quality of life of these patients treated with these 2 regimens.
Determine the side effects of GH in these patients.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Growth Hormone Deficiency	Drug: growth hormone	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114-2617
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110-0250
4	Case Western Reserve University	Cleveland	Ohio	United States	44106
5	Oregon Health Sciences University	Portland	Oregon	United States	97201-3098
6	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania	United States	19104
7	Rhode Island Hospital	Providence	Rhode Island	United States	02903