Status:
COMPLETED
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Involutional Osteoporosis
Eligibility:
FEMALE
55-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Eligibility Criteria
Inclusion
- Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
- Patients having radiographically confirmed vertebral (T4-L4) fractures
- Other inclusion criteria as specified in the study protocol
Exclusion
- Patients having secondary osteoporosis or another condition that presents low bone mass
- Patients having findings on X-ray that affect evaluation of vertebral fracture
- Patients that have been administered bisphosphonate derivatives
- Other exclusion criteria as specified in the study protocol
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00212667
Start Date
August 1 2002
Last Update
October 11 2012
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