Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2)
Not Applicable
- Conditions
- Osteoporosis
- Registration Number
- JPRN-UMIN000000991
- Lead Sponsor
- Japan Osteoporosis Society/A-TOP consortium
- Brief Summary
Concurrent treatment with vitamin K2 and risedronate was not efficacious compared with monotherapy with risedronate in terms of fracture prevention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 1983
Inclusion Criteria
Not provided
Exclusion Criteria
1.Using warfarin 2.Secondary osteoporosis and low bone mass disease except osteoporosis 3.Having contraindication in using drugs 4.Hypothyroidism and hyperparathyroidism 5.Disfunction of communication of the intention 6.Prevalent vertebral fracture>=6 7.Deformation of vertebra 8.Abnormal heart function,abnormal hepatic function,abnormal kidney function 9.Taken bisphosphonate within previous 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incident vertebral fracture rate and incident nonvertebral fracture rate
- Secondary Outcome Measures
Name Time Method Bone mineral density,stature,QOL, undercarboxylated osteocalcin,safety