BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
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ClinicalTrials.gov Identifier: NCT00545909 |
Recruitment Status :
Completed
First Posted : October 17, 2007
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Osteoporosis | Drug: ibandronate [Bonviva/Boniva] | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 585 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
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) |
- Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ]
- Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ]
- Tolerability; SAEs. [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545909

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00545909 |
Other Study ID Numbers: |
ML19913 |
First Posted: | October 17, 2007 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Ibandronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |