An interventional study of human parathyroid hormone in Osteoporosis, sponsored by Columbia University. Completed at 1 site in United States. Open to male participants aged 29 Years to 67 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
OBJECTIVES:
I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
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
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 36 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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:
This study is completed, as verified in Jan 2000. You cannot join it, but the record below documents what was studied.
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Columbia University