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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

OBJECTIVES:

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Hormones; Parathyroid Hormone

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