Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan - Multi-center Randomized Trial with Arendoronate and alfa-calcidol
Not Applicable
- Conditions
- Osteoporosis
- Registration Number
- JPRN-C000000001
- Lead Sponsor
- Japan Osteoporosis Society/ A-TOP consortium
- Brief Summary
The combination therapy was no more effective for overall vertebral fracture prevention. However, subgroup analysis has shown that it was more effective for fracture prevention in patients with severe vertebral deformity, multiple prevalent vertebral fractures, and for non-vertebral weight-bearing bone fracture prevention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 2164
Inclusion Criteria
Not provided
Exclusion Criteria
Bone disease other than osteoporosis, having contraindication in using drugs, disfunction of communication of the intention, deformation of vertebra, hyperthyroidism, hyperparathyroidism, abnormal heart function, abnormal hepatic function, abnormal kidney function, taken bisphosponate within previous 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incident vertebral fracture rate
- Secondary Outcome Measures
Name Time Method Period of incident vertebral fracture, non-vertebvral fracture rate, bone mineral density, QOL, Sreum vitamin D, safety