Status:
COMPLETED
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Primary Osteoporosis
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administratio...
Eligibility Criteria
Inclusion
- Patients with fragile bone fracture
- Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
- Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
- Ambulatory
Exclusion
- Patients with disease lowering bone volume secondarily (secondary osteoporosis)
- Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
- Patient with disorder delaying the passage of food through esophagus
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1265 Patients enrolled
Trial Details
Trial ID
NCT00447915
Start Date
March 1 2007
End Date
December 1 2011
Last Update
August 2 2012
Active Locations (4)
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1
Chubu/Kansai region
Chubu/Kansai, Japan
2
Chugoku/Kyusyu region
Chugoku/Kyusyu, Japan
3
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
4
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan