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



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

For Condition: Growth Hormone Deficiency,Osteoporosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Pennsylvania
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 72

Location and Contact Information:

Overall Study Official:
PeterSnyder,  Study Chair,  University of Pennsylvania

Oregon Health Sciences University
Portland,  Oregon,  97201-3098
United States
 

University of Pennsylvania School of Medicine
Philadelphia,  Pennsylvania,  19104
United States
 

Massachusetts General Hospital
Boston,  Massachusetts,  02114-2617
United States
 

Mayo Clinic
Rochester,  Minnesota,  55905
United States
 

Case Western Reserve University
Cleveland,  Ohio,  44106
United States
 

Rhode Island Hospital
Providence,  Rhode Island,  02903
United States
 

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110-0250
United States
 


Additional Information:
Study ID Numbers:
  199/15433;  UPSM-209300,LILLY-B9R-US-GDEO
Study Start Date: April 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006394

Other Growth Hormone Deficiency Studies:
1. Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

2. Testosterone and Growth Hormone for Bone Loss in Men

3. Study of Pituitary Size and Function in Familial Dwarfism of Sindh

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