Expired Study
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New York, New York 10032


OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Study summary:

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. Completion date provided represents the completion date of the grant per OOPD records


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



Primary Contact:

Study Chair
John Paul Bilezikian
Columbia University

Backup Contact:


Location Contact:

New York, New York 10032
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 18, 2018

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