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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 administration every day. To evaluate also the dose response of R484iv.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronic acid 0.5mg | Drug | 0.5mg(i.v.)/month for 35 months |
| |
| RIS placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of vertebral fracture | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of bone density of lumbar spine and proximal part of femur from baseline | 36 months | |
| Change of bone absorption marker from baseline | 36 months | |
| Change of bone formation marker from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshitaka Nakamura | University of Occupational and Environment Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu/Kansai region | Chubu/Kansai | Japan | ||||
| Chugoku/Kyusyu region |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
0 mg(p.o.)/day for 36 months |
|
| 1.0mg ibandronic acid | Drug | 1.0mg(i.v.)/month for 35 months |
|
| ibandronic acid placebo | Drug | 0mg(i.v.)/month for 35 months |
|
| 2.5mg RIS | Drug | 2.5 mg(p.o.)/day for 36 months |
|
| Calcium and Vitamine D3 | Dietary Supplement | Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months |
|
| 36 months |
| Chugoku/Kyusyu |
| Japan |
| Hokkaido/Tohoku region | Hokkaido/Tohoku | Japan |
| Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |