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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00081653 |
Purpose
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. 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 |
|
Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase IV |
| MedlinePlus related topics: | Menopause Osteoporosis |
| ChemIDplus related topics: | Ibandronate sodium Ibandronic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549 |
| Enrollment: | 719 |
| Study Completion Date: | May 2008 |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 3 years
|
| 2: Active Comparator |
Drug: ibandronate [Bonviva/Boniva]
100mg po monthly for 3 years
|
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 31 Study Locations |
| Hoffmann-La Roche |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | MA17903 |
| First Received: | April 19, 2004 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00081653 |
| Health Authority: | United States: Food and Drug Administration |
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