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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00493532 |
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Condition | Intervention | Phase |
---|---|---|
Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-Menopausal Osteoporosis. |
Estimated Enrollment: | 100 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
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Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
TAIPEI, Taiwan, 100 | |
TAIPEI, Taiwan, 112 | |
TAICHUNG, Taiwan, 404 | |
TAINAN, Taiwan, 704 | |
TAOYUAN, Taiwan, 333 | |
TAIPEI, Taiwan, 886 | |
TAICHUNG, Taiwan, 407 | |
KAOHSIUNG, Taiwan, 804 | |
CHANGHUA, Taiwan, 500 | |
KAOHSIUNG, Taiwan, 807 | |
KAOHSIUNG, Taiwan, 833 | |
TAINAN, Taiwan, 710 | |
CHAI YI, Taiwan, 613 | |
TAICHUNG, Taiwan, 402 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20882 |
Study First Received: | June 27, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00493532 History of Changes |
Health Authority: | Taiwan: Department of Health |
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 |