Status:
COMPLETED
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Postmenopausal Osteoporosis
Osteoporosis
Eligibility:
FEMALE
46-85 years
Phase:
PHASE2
Brief Summary
Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone format...
Detailed Description
In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, ...
Eligibility Criteria
Inclusion
- Three or more years after menopause
- Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae
Exclusion
- Cannot walk without assistance
- Significant heart, kidney, liver, or malignant disease
- Current alcohol abuse
- Major psychiatric disorders
- Other current or past disorders known to affect bone
- Use of medications known to affect bone for \> 7 days in the past 12 months
- Use of bisphosphonates or fluoride
- Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count
- Elevated calcium levels in 24-hour urine collection
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00086619
Start Date
May 1 2004
End Date
December 1 2009
Last Update
October 30 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114