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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 16, 2007 | ||||
| Last Updated Date | May 13, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Comparison of the proportion of patients with >=83% adherence at 6 months (ie 5 of 6 possible administrations)to Bonviva in the feedback vs no feedback group. | ||||
| Change History | Complete list of historical versions of study NCT00545909 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Compliance: Patient satisfaction at 6 months by OPSAT-Q and OPPS. Safety: Tolerability, SAEs | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis | ||||
| Official Title ICMJE | A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. | ||||
| Brief Summary | This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Post-Menopausal Osteoporosis | ||||
| Intervention ICMJE | Drug: ibandronate [Bonviva/Boniva] | ||||
| 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 | 585 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 55 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Belgium, Greece, Ireland, Luxembourg | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00545909 | ||||
| Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | ML19913 | ||||
| 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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