Status:
COMPLETED
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Osteoporosis
Bone Loss, Age-Related
Eligibility:
All Genders
45+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily...
Eligibility Criteria
Inclusion
- Patients whose bone mineral density is \<70% of Young Adult Mean (YAM), or \<80% of YAM who have fragile fracture history
- Patients can walk on his/her own
- Written informed consent has been obtained from the patient.
Exclusion
- Sequential osteoporosis patients or patients with other disorders showing low bone mass
- Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
- Patients who are unable to keep raising or standing for ≥30 min
- Patients with peptic ulcer
- Patients who have experienced anamnesis or gastrectomy (total extraction)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT00794443
Start Date
November 1 2008
End Date
April 1 2010
Last Update
May 4 2015
Active Locations (5)
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1
Hokkaido, Japan
2
Kansai, Japan
3
Kantou, Japan
4
Kyusyu, Japan