View Clinical Trial (Medical Research Study)
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis - NCT00004406-10032(Clinical Trial 112594)
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Osteoporosis |
| Purpose: |
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OBJECTIVES:
I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men
with idiopathic osteoporosis.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Columbia University College of Physicians and Surgeons
New York, NY 10032
United States
Primary Contact:
John Paul Bilezikian
Phone: 212-305-6238 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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