Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis; Growth Hormone Deficiency
Intervention: growth hormone (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Peter Snyder, Study Chair, Affiliation: University of Pennsylvania
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114-2617, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri 63110-0250, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
Oregon Health Sciences University, Portland, Oregon 97201-3098, United States
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Starting date: April 1997
Last updated: June 23, 2005
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