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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
585
150mg po monthly for 6 months (+ feedback)
150mg po monthly for 6 months (- feedback)
Unnamed facility
Bregenz, Austria
Unnamed facility
Graz, Austria
Unnamed facility
Innsbruck, Austria
Unnamed facility
Linz, Austria
Unnamed facility
Salzburg, Austria
Unnamed facility
Vienna, Austria
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Time frame: 6 months
Patient satisfaction by OPSAT-Q and OPPS.
Time frame: 6 months
Tolerability; SAEs.
Time frame: Throughout study
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Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
...and 47 more locations