BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
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.
1 other identifier
interventional
585
5 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
Typical duration for phase_4
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedNovember 2, 2016
November 1, 2016
2.4 years
October 16, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
6 months
Secondary Outcomes (2)
Patient satisfaction by OPSAT-Q and OPPS.
6 months
Tolerability; SAEs.
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- ambulatory post-menopausal women with osteoporosis;
- years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake \> 6 months ago).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Bregenz, 6900, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1021, Austria
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Vienna, 1060, Austria
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Vienna, 1100, Austria
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Vienna, 1130, Austria
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Vienna, 1150, Austria
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Vienna, 1160, Austria
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Vöcklabruck, 4840, Austria
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Aalst, 9300, Belgium
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Antwerp, 2018, Belgium
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Antwerp, 2020, Belgium
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Aye, 6900, Belgium
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Braine-l'Alleud, 1420, Belgium
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Bruges, 8000, Belgium
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Brussels, 1000, Belgium
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Brussels, 1020, Belgium
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Brussels, 1040, Belgium
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Brussels, 1180, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Dinant, 5500, Belgium
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Ekeren, 2180, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Godinne, 5530, Belgium
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Hasselt, 3500, Belgium
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Jambes, 5100, Belgium
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Knokke, 8300, Belgium
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Kortrijk, 8500, Belgium
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La Louvière, 7100, Belgium
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Liège, 4000, Belgium
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Liège, 4020, Belgium
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Mechelen, 2800, Belgium
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Merksem, 2170, Belgium
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Mons, 7000, Belgium
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Ostend, 8400, Belgium
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Roeselare, 8800, Belgium
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Sijsele, 8340, Belgium
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Tournai, 7500, Belgium
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Turnhout, 2300, Belgium
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Waremme, 4300, Belgium
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Wilrijk, 2610, Belgium
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Athens, 10682, Greece
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Athens, 16673, Greece
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Kifissia, 14561, Greece
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Larissa, 41110, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 55132, Greece
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Thessaloniki, 56429, Greece
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Gorey, Ireland
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Tipperary, Ireland
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Luxembourg, 2311, Luxembourg
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Luxembourg, 2763, Luxembourg
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
March 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
November 2, 2016
Record last verified: 2016-11