Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Chugai Pharmaceutical |
---|---|
Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00447915 |
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.
Condition | Intervention | Phase |
---|---|---|
Primary Osteoporosis |
Drug: ibandronic acid 0.5mg Drug: RIS placebo Drug: 1.0mg ibandronic acid Drug: ibandronic acid placebo Drug: 2.5mg RIS Dietary Supplement: Calcium and Vitamine D3 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index - |
Estimated Enrollment: | 1200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronic acid 0.5mg
0.5mg(i.v.)/month for 35 months
Drug: RIS placebo
0 mg(p.o.)/day for 36 months
Dietary Supplement: Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
|
2: Experimental |
Drug: RIS placebo
0 mg(p.o.)/day for 36 months
Drug: 1.0mg ibandronic acid
1.0mg(i.v.)/month for 35 months
Dietary Supplement: Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
|
3: Active Comparator |
Drug: ibandronic acid placebo
0mg(i.v.)/month for 35 months
Drug: 2.5mg RIS
2.5 mg(p.o.)/day for 36 months
Dietary Supplement: Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
|
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido/Tohoku region | |
Hokkaido/Tohoku, Japan | |
Kanto/Koshinetsu region | |
Kanto/Koshinetsu, Japan | |
Chubu/Kansai region | |
Chubu/Kansai, Japan | |
Chugoku/Kyusyu region | |
Chugoku/Kyusyu, Japan |
Study Chair: | Toshitaka Nakamura | University of Occupational and Environment Health |
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | JA19761 |
Study First Received: | March 14, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00447915 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Tocopherol acetate Antioxidants Fractures, Bone Spinal Fractures Osteoporosis Bone Density Conservation Agents Trace Elements Bone Diseases, Metabolic Bone Diseases Alpha-Tocopherol |
Tocopherols Calcium, Dietary Vitamin E Diphosphonates Musculoskeletal Diseases Ibandronic acid Vitamins Tocotrienols Micronutrients Risedronic acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases |
Protective Agents Pharmacologic Actions Vitamin E Diphosphonates Musculoskeletal Diseases Ibandronic acid Vitamins Micronutrients |