The U.S. FDA ( Food and Drug Administration ) approved once- monthly oral Ibandronate ( Boniva ) 150 mg tablets, the first and only once-a-month drug for the treatment of postmenopausal osteoporosis.

Once-monthly Boniva offers the advantage of reducing the number of pills to 12 tablets per year. This may improve persistence.

Once-monthly Boniva is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva.

Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis.

Once-monthly oral Boniva ( 150 mg ) was approved based on results from the MOBILE study ( Monthly Oral iBandronate In LadiEs ), a randomized, double-blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis.

MOBILE showed the following:

- The monthly dose was at least equivalent to the daily dose in increasing BMD after one year at the lumbar spine and other skeletal sites

- The mean increase from baseline in lumbar spine BMD was 4.9 percent in the once-monthly group and 3.9 percent in the daily group ( p=0.002 )

- The once-monthly group also had consistently higher BMD increases at the other skeletal sites compared to the daily group

Ibandronate is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva.

Ibandronate, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer.

Ibandronate is not recommended in patients with severe renal impairment.

Adequate intake of calcium and Vitamin D is important in all patients.

The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain ( Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent ), hypertension ( 6.3 percent vs. 7.3 percent ), dyspepsia ( 5.6 percent vs. 7.1 percent ), arthralgia ( 5.6 percent vs. 3.5 percent ), nausea ( 5.1 percent vs. 4.8 percent ) and diarrhea ( 5.1 percent vs. 4.1 percent ).

Source : Roche & GlaxoSmithKline, 2005


XagenaMedicine2005