A Phase 4 interventional study of ibandronate [Bonviva/Boniva] and ibandronate [Bonviva/Boniva] in Postmenopausal Osteoporosis, sponsored by Hoffmann-La Roche. Completed at 57 sites in 5 countries. Open to female participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.
This study's enrollment of 585 is above the median of 110 across 265 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Drug: ibandronate [Bonviva/Boniva]
Drug: ibandronate [Bonviva/Boniva]
Drug page: Ibandronic Acid
150mg po monthly for 6 months (+ feedback)
Drug page: Ibandronic Acid
150mg po monthly for 6 months (- feedback)
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
The record gives a start of Mar 2006, a primary completion of Aug 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibandronic Acid
Osteoporosis, Postmenopausal →