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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 15, 2006 | ||||
| Last Updated Date | May 13, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Proportion of patients preferring once monthly dosing with Boniva over once weekly dosing with risedronate | ||||
| Change History | Complete list of historical versions of study NCT00377234 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Efficacy: Convenience of monthly Boniva vs weekly risedronate; change in serum CTX at end of 1st treatment period; upper gastrointestinal symptoms during 1st treatment period. Safety: AEs, lab parameters | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. | ||||
| Official Title ICMJE | Randomized, Open-Label, Multi-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-Sequence and Two-Period Crossover Study. | ||||
| Brief Summary | This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Post-Menopausal Osteoporosis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 356 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 55 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00377234 | ||||
| Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | MA19547 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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