Status:
COMPLETED
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Osteoporosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
Eligibility Criteria
Inclusion
- Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures
Exclusion
- Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
1262 Patients enrolled
Trial Details
Trial ID
NCT00680953
Start Date
May 1 2008
End Date
July 1 2012
Last Update
March 12 2015
Active Locations (4)
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1
Fukuoka, Japan
2
Osaka, Japan
3
Sapporo, Japan
4
Tokyo, Japan