BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
WIEN 1100, Austria
WIEN 1160, Austria
BREGENZ 6900, Austria
SALZBURG 5020, Austria
WIEN 1060, Austria
GRAZ 8036, Austria
WIEN 1130, Austria
LINZ 4020, Austria
WIEN 1021, Austria
WIEN 1150, Austria
VÖCKLABRUCK 4840, Austria
INNSBRUCK 6020, Austria
GENT 9000, Belgium
LIEGE 4000, Belgium
BRUXELLES 1020, Belgium
BRUXELLES 1000, Belgium
WAREMME 4300, Belgium
GODINNE 5530, Belgium
EKEREN 2180, Belgium
ANTWERPEN 2020, Belgium
WILRIJK 2610, Belgium
OOSTENDE 8400, Belgium
KORTRIJK 8500, Belgium
BRUGGE 8000, Belgium
ROESELARE 8800, Belgium
KNOKKE 8300, Belgium
GENT 9000, Belgium
LIEGE 4000, Belgium
DINANT 5500, Belgium
SIJSELE 8340, Belgium
BRUXELLES 1180, Belgium
MERKSEM 2170, Belgium
LIEGE 4020, Belgium
CHARLEROI 6000, Belgium
BRUXELLES 1000, Belgium
LA LOUVIERE 7100, Belgium
BRUXELLES 1200, Belgium
GENK 3600, Belgium
MONS 7000, Belgium
TURNHOUT 2300, Belgium
AALST 9300, Belgium
TOURNAI 7500, Belgium
AYE 6900, Belgium
JAMBES 5100, Belgium
ANTWERPEN 2018, Belgium
MECHELEN 2800, Belgium
HASSELT 3500, Belgium
BRAINE L'ALLEUD 1420, Belgium
BRUXELLES 1040, Belgium
KIFISSIA 14561, Greece
LARISSA 41110, Greece
THESSALONIKI 55132, Greece
ATHENS 10682, Greece
THESSALONIKI 54636, Greece
THESSALONIKI 56429, Greece
TIPPERARY, Ireland
GOREY, Ireland
LUXEMBOURG 2763, Luxembourg
LUXEMBOURG 2311, Luxembourg
Additional Information
Starting date: March 2006
Ending date: September 2007
Last updated: June 17, 2008
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