Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
NCT ID: NCT00447915
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1265 participants
INTERVENTIONAL
2007-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ibandronic acid 0.5mg
0.5mg(i.v.)/month for 35 months
RIS placebo
0 mg(p.o.)/day for 36 months
Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
2
RIS placebo
0 mg(p.o.)/day for 36 months
1.0mg ibandronic acid
1.0mg(i.v.)/month for 35 months
Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
3
ibandronic acid placebo
0mg(i.v.)/month for 35 months
2.5mg RIS
2.5 mg(p.o.)/day for 36 months
Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
Interventions
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ibandronic acid 0.5mg
0.5mg(i.v.)/month for 35 months
RIS placebo
0 mg(p.o.)/day for 36 months
1.0mg ibandronic acid
1.0mg(i.v.)/month for 35 months
ibandronic acid placebo
0mg(i.v.)/month for 35 months
2.5mg RIS
2.5 mg(p.o.)/day for 36 months
Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
60 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Toshitaka Nakamura
Role: STUDY_CHAIR
University of Occupational and Environment Health
Locations
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Chubu/Kansai region
Chubu/Kansai, , Japan
Chugoku/Kyusyu region
Chugoku/Kyusyu, , Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, , Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, , Japan
Countries
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Other Identifiers
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JA19761
Identifier Type: -
Identifier Source: org_study_id