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Randomized Study of Human Parathyroid Hormone in Middle-Aged Men with Idiopathic Osteoporosis



Randomized Study of Human Parathyroid Hormone in Middle-Aged Men with Idiopathic Osteoporosis

For Condition: Osteoporosis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Columbia University
Synopsis: OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years. Patients are followed regularly for unacceptable toxicities.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 29 Years/67 Years
Genders: Male
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5) No family history of male osteoporosis No other metabolic bone disease --Prior/Concurrent Therapy-- Endocrine therapy: - No concurrent glucocorticoid therapy - No prior steroid use Surgery: No prior gastrointestinal tract surgery Other: No prior or concurrent anticonvulsant therapy --Patient Characteristics-- Hematopoietic: Normal CBC Hepatic: Normal liver function Renal: Normal renal function Other: - Normal thyroid function - Normal adrenal function - Normal gonadal status - No myeloma or other malignancy - No alcoholism, hypercortisolism or diabetes mellitus - No gastrointestinal tract disease or disorder associated with malabsorption
Total Enrollment: 36

Location and Contact Information:

Overall Study Official:
JohnBilezikian,  Study Chair,  Columbia University

Columbia University College of Physicians and Surgeons *Recruiting*
New York City,  New York,  10032
United States
Recruiting John  Bilezikian 212-305-6238


Additional Information:
Study ID Numbers:  199/13293;  CPS-CU-FDR001024
Study Start Date: October 1999
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004406

Other Osteoporosis Studies:
1. To evaluate the ability of an investigational drug to reduce the rate of all subsequent skeletal fractures after a hip fracture.

2. A School-Based Osteoporosis Prevention Program for Adolescent Girls

3. Bone Loss in Premenopausal Women with Depression

4. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

5. Effects of Jumping on Growing Bones

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