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BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group

Secondary outcome:

Patient satisfaction by OPSAT-Q and OPPS.

Tolerability; SAEs.

Eligibility

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

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.

Locations and Contacts

Bregenz 6900, Austria

Graz 8036, Austria

Innsbruck 6020, Austria

Linz 4020, Austria

Salzburg 5020, Austria

Vöcklabruck 4840, Austria

Wien 1021, Austria

Wien 1060, Austria

Wien 1160, Austria

Wien 1130, Austria

Wien 1150, Austria

Wien 1100, Austria

Aalst 9300, Belgium

Antwerpen 2018, Belgium

Antwerpen 2020, Belgium

AYE 6900, Belgium

Braine L'alleud 1420, Belgium

Brugge 8000, Belgium

Bruxelles 1200, Belgium

Bruxelles 1000, Belgium

Bruxelles 1020, Belgium

Bruxelles 1180, Belgium

Bruxelles 1040, Belgium

Charleroi 6000, Belgium

Dinant 5500, Belgium

Ekeren 2180, Belgium

Genk 3600, Belgium

Gent 9000, Belgium

Godinne 5530, Belgium

Hasselt 3500, Belgium

Jambes 5100, Belgium

Knokke 8300, Belgium

Kortrijk 8500, Belgium

La Louviere 7100, Belgium

Liege 4020, Belgium

Liege 4000, Belgium

Mechelen 2800, Belgium

Merksem 2170, Belgium

Mons 7000, Belgium

Oostende 8400, Belgium

Roeselare 8800, Belgium

Sijsele 8340, Belgium

Tournai 7500, Belgium

Turnhout 2300, Belgium

Waremme 4300, Belgium

Wilrijk 2610, Belgium

Athens 10682, Greece

Athens 16673, Greece

Kifissia 14561, Greece

Larissa 41110, Greece

Thessaloniki 55132, Greece

Thessaloniki 56429, Greece

Thessaloniki 54636, Greece

Gorey, Ireland

Tipperary, Ireland

Luxembourg 2763, Luxembourg

Luxembourg 2311, Luxembourg

Additional Information

Starting date: March 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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