
The tolerability you want in a once-monthly, film-coated tablet
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In the MOBILE trial, overall adverse events (AEs) for the 150-mg once-monthly
dose were similar to the 2.5-mg daily dose
BONIVA
2.5 mg daily AEs similar to placebo
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In the BONE trial, overall AEs for the 2.5-mg daily dose were similar to
placebo
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In patients taking aspirin, NSAIDs, PPIs and H2 blockers, the
incidence of upper gastrointestinal (GI) AEs was similar to placebo
*The Monthly Oral IBandronate In LadiEs (MOBILE) trial was a 2-year, randomized, double-blind, phase III, noninferiority trial designed to confirm that once-monthly dosing was as effective as daily dosing in increasing lumbar spine BMD at year 1. Women with postmenopausal osteoporosis (N=1609) were assigned to one of four oral ibandronate regimens including 2.5 mg daily (n=395) and 150 mg once-monthly (n=396). All patients took 400 IU vitamin D and 500 mg calcium supplementation each day.
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Withdrawal rate due to AEs was 8% for 150 mg once-monthly and 9% for 2.5 mg
daily
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Patients with a history of GI disease and/or patients taking aspirin, NSAIDs,
PPIs and H2 blockers were not excluded from the BONE and MOBILE
trials
BONIVA tablets
are contraindicated in patients unable to stand or sit upright for at least 60
minutes or with uncorrected hypocalcemia.
BONIVA
is contraindicated in patients with known hypersensitivity to
BONIVA
or any of its components.