BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
NCT ID: NCT00545909
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
585 participants
INTERVENTIONAL
2006-03-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
2
ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)
Interventions
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ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
55 Years
85 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bregenz, , Austria
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vöcklabruck, , Austria
Aalst, , Belgium
Antwerp, , Belgium
Antwerp, , Belgium
Aye, , Belgium
Braine-l'Alleud, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Dinant, , Belgium
Ekeren, , Belgium
Genk, , Belgium
Ghent, , Belgium
Godinne, , Belgium
Hasselt, , Belgium
Jambes, , Belgium
Knokke, , Belgium
Kortrijk, , Belgium
La Louvière, , Belgium
Liège, , Belgium
Liège, , Belgium
Mechelen, , Belgium
Merksem, , Belgium
Mons, , Belgium
Ostend, , Belgium
Roeselare, , Belgium
Sijsele, , Belgium
Tournai, , Belgium
Turnhout, , Belgium
Waremme, , Belgium
Wilrijk, , Belgium
Athens, , Greece
Athens, , Greece
Kifissia, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Gorey, , Ireland
Tipperary, , Ireland
Luxembourg, , Luxembourg
Luxembourg, , Luxembourg
Countries
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Other Identifiers
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ML19913
Identifier Type: -
Identifier Source: org_study_id