Forty-four million Americans over 50 years of age are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.

Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With once-monthly Boniva, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments.

Osteoporosis, Smoking, Obesity

"Boniva is the first and only once-monthly osteoporosis medication that maintains and actually builds bone density," said Ronald Emkey, M.D., clinical trial investigator and Medical Director of Radiant Research, Reading, Pennsylvania. "The approval of this medication is significant, because it offers patients a new treatment option that is effective and easy to take."

This new treatment option comes in the wake of the Surgeon General's Report elevating osteoporosis to a major public health threat on a par with smoking and obesity. Forty-four million Americans over 50 years of age are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.

To improve persistence, the Surgeon General's Report has recommended, among various measures, simplifying and organizing treatment regimens.

Treatment and Prevention

"Osteoporosis is a serious, widespread and growing public health threat," said Judith Cranford, Executive Director, National Osteoporosis Foundation. "We welcome any new treatment options, such as Boniva, that will help patients address this all too prevalent disease."

Once-monthly oral Boniva is not currently approved for use outside of the US, 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 tablets and Boniva 2.5 mg daily tablets are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva is expected to be available by prescription in US pharmacies in April.

Clinical Trial Results

Daily Boniva (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis over a three-year period.

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.