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

Condition	Treatment or Intervention
Osteoporosis	Drug: human parathyroid hormone

Further Study Details: 

Expected Total Enrollment:  36

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.

Ages Eligible for Study:  29 Years   -   67 Years,  Genders Eligible for Study:  Male

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

New York
      Columbia University College of Physicians and Surgeons, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

John Paul Bilezikian,  Study Chair,  Columbia University   

Study ID Numbers:  199/13293; CPS-CU-FDR001024
Record last reviewed:  January 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004406
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08