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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00048074 |
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Condition | Intervention | Phase |
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Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis |
Enrollment: | 1395 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
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2: Experimental |
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
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3: Experimental |
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
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4: Active Comparator |
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
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Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BM16550 |
Study First Received: | October 24, 2002 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00048074 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ibandronic acid Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Menopause |
Ibandronic acid Musculoskeletal Diseases Physiological Effects of Drugs Osteoporosis, Postmenopausal Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |