This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
596
150mg po monthly for 12 months (with feedback)
150mg po monthly for 12 months (without feedback)
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
Time frame: 12 months
Differences between groups in persistence
Time frame: 6 months
QoL and patient satisfaction
Time frame: 6 and 12 months
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Agen, France
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Aix-les-Bains, France
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Albert, France
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Amboise, France
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Amiens, France
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Amiens, France
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Andernos-les-Bains, France
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Andrézieux-Bouthéon, France
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Angers, France
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Angoulême, France
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