Boniva Is Effective At Increasing Bone Mineral Density In Postmenopausal Women With Osteoporosis

Women With Osteoporosis

Women with postmenopausal osteoporosis receiving once-monthly Boniva (ibandronate sodium) achieved clinically comparable increases in bone mineral density (BMD) to those receiving once-weekly Fosamax (alendronate sodium).

The study, called MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis iNtervention), is the first head-to-head non-inferiority study comparing the efficacy and safety of once-monthly Boniva to once-weekly Fosamax. Efficacy was determined as improvements in BMD of the lumbar spine and total hip over a 12-month period, using a predetermined non-inferiority margin.

In this study, once-monthly Boniva and once-weekly Fosamax were clinically comparable at increasing average BMD at both the lumbar spine and total hip. Overall, adverse events were similar in both treatment groups.

"For clinicians, the data reinforce the fact that their patients can benefit from once-monthly dosing," said Sol Epstein, MD, Professor of Medicine and Geriatrics at Mount Sinai Medical School in New York and investigator of the MOTION study.

Boniva and Fosamax are both bisphosphonates, the most frequently prescribed class of medication for the treatment and prevention of postmenopausal osteoporosis.

About MOTION

MOTION was a multicenter, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial that included 1,733 treated women, 55 to 84 years old, with postmenopausal osteoporosis. The women took either once-monthly oral Boniva 150 mg or once-weekly oral Fosamax 70 mg for 12 months. They also received vitamin D and calcium supplements. The primary endpoints were the relative change (%) from baseline in average BMD of the lumbar spine and the total hip after 12 months of treatment. Clinical difference between the two groups was defined as BMD changes of greater than or equal to 1.41% for lumbar spine and greater than or equal to 0.87% for total hip.

The primary efficacy analysis was based on the per protocol population. By 12 months, increase in average lumbar spine BMD was 5.10% among those taking Boniva and 5.78% among those taking Fosamax. Increase in average total hip BMD was 2.94% and 3.03%, respectively. In addition, treatment with Boniva versus Fosamax provided comparable increases in BMD at the trochanter (4.2% for both) and in the femoral neck (2.1% vs. 2.3%, respectively, in a post-hoc analysis). A low BMD is one of the most important underlying causes of fractures in older adults. However, fracture was not an efficacy endpoint in the trial.

In the safety analysis, the overall incidence of adverse events was similar between the treatment groups. The most frequently reported adverse events (reported by at least 5% of women in either treatment group) included hypertension, dyspepsia, back pain, arthralgia, nasopharyngitis, and influenza. Of the serious adverse events, less than 1% per group were considered treatment related.

About Osteoporosis

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. In the U.S. today, 10 million people -- eight million of them women -- are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia) placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020. Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.

About Once-Monthly Oral Boniva

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

Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.