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New Study Shows Once-Monthly Boniva(R) is as Clinically Effective as Once-Weekly Fosamax(R) at Increasing Bone Mineral Density in Postmenopausal Women With Osteoporosis
Date:9/19/2007

f 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
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SOURCE Roche and GSK
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