Status:
COMPLETED
Alendronate and/or Parathyroid Hormone for Osteoporosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Osteoporosis
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
Brief Summary
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postm...
Detailed Description
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initia...
Eligibility Criteria
Inclusion Criteria:
- Lumbar spine or hip BMD T-score less than or equal to minus 2.0
- Postmenopausal at least 5 years
- Fully ambulatory
- Able to give informed consent
Exclusion Criteria:
- No concurrent illnesses that cause bone loss
- No recent drug treatment for osteoporosis
- No recent fracture
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00000400
Start Date
August 1 1999
End Date
June 1 2006
Last Update
December 9 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114