- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006394
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114-2617
- Massachusetts General Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Health Sciences University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania School of Medicine
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Peter Snyder, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Bone Diseases, Endocrine
- Pituitary Diseases
- Dwarfism
- Bone Diseases, Developmental
- Hypopituitarism
- Osteoporosis
- Dwarfism, Pituitary
- Endocrine System Diseases
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- 199/15433
- UPSM-209300
- LILLY-B9R-US-GDEO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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