Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
Status
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About
OBJECTIVES:
I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
Full description
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
Enrollment
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Volunteers
Inclusion and exclusion 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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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