All daily bisphosphonate therapies for the treatment and prevention of postmenopausal osteoporosis were approved by demonstrating fracture reduction versus placebo. Approval of extended dosing regimens for bisphosphonates was based on demonstrating increases in bone mineral density (BMD) similar to those of the approved daily dose.

Results from pivotal BONE trial^†—2.5 mg daily

BONIVA significantly reduces vertebral fracture risk vs placebo

BONIVA significantly increases BMD as early as 6 months²

^†The Oral IBandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) consisted of 2946 women aged 55 to 80 years with postmenopausal osteoporosis. In this 3-year, double-blind trial, women were randomized to one of three regimens, including placebo (n=975) and BONIVA 2.5 mg daily (n=977). All patients took 400 IU vitamin D and 500 mg calcium supplementation each day. The primary endpoint was the incidence of new vertebral fractures after 3 years of treatment.

Results from pivotal MOBILE trial^‡—

BONIVA 150 mg once-monthly shown to be as effective in increasing BMD as daily BONIVA³

^‡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.

150 mg once-monthly had consistently higher BMD increases at all measured skeletal sites

*BONIVA is indicated for treatment and prevention of osteoporosis in postmenopausal women.
In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures. BONIVA may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.

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