Status:
COMPLETED
Effects of Parathyroid Hormone in Men With Osteoporosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Osteoporosis
Eligibility:
MALE
46-85 years
Phase:
PHASE3
Brief Summary
Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH a...
Detailed Description
Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, l...
Eligibility Criteria
Inclusion Criteria:
- Bone density of the spine or femoral neck two standard deviations below the mean of young adult men
- Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels
Exclusion Criteria:
- Significant cardiac, renal, hepatic, or malignant disease.
- Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism
- Active peptic ulcer disease or severe reflux
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00000427
Start Date
September 1 1999
End Date
October 1 2005
Last Update
December 9 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114