BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545909
First received: October 16, 2007
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Tolerability; SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Enrollment: | 585 |
| Study Start Date: | March 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
|
| Active Comparator: 2 |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)
|
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ambulatory post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
Exclusion Criteria:
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- administration of any drug, or presence of active disease, known to influence bone metabolism;
- uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
- history of major upper gastrointestinal disease.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00545909
Show 57 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545909
Show 57 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00545909 History of Changes |
| Other Study ID Numbers: | ML19913 |
| Study First Received: | October 16, 2007 |
| Last Updated: | September 1, 2016 |
| Health Authority: | Belgium: Agence federale des medicaments at des produits de sante |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Ibandronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016