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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

Thursday, September 20, 2007 General News J E 4
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HONOLULU, Sept. 19 Women with postmenopausal osteoporosisreceiving once-monthly Boniva(R) (ibandronate sodium) achieved clinicallycomparable increases in bone mineral density (BMD) to those receivingonce-weekly Fosamax(R) (alendronate sodium), according to a new studypresented at the 29th Annual Meeting of the American Society for Bone andMineral Research.

The study, called MOTION (Monthly Oral Therapy with Ibandronate forOsteoporosis iNtervention), is the first head-to-head non-inferiority studycomparing the efficacy and safety of once-monthly Boniva to once-weeklyFosamax. Efficacy was determined as improvements in BMD of the lumbar spineand total hip over a 12-month period, using a predetermined non-inferioritymargin.

In this study, once-monthly Boniva and once-weekly Fosamax were clinicallycomparable 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 canbenefit from once-monthly dosing," said Sol Epstein, MD, Professor of Medicineand Geriatrics at Mount Sinai Medical School in New York and investigator ofthe MOTION study.

Boniva and Fosamax are both bisphosphonates, the most frequentlyprescribed class of medication for the treatment and prevention ofpostmenopausal osteoporosis.

About MOTION

MOTION was a multicenter, randomized, double-blind, double-dummy,parallel-group, non-inferiority trial that included 1,733 treated women, 55 to84 years old, with postmenopausal osteoporosis. The women took eitheronce-monthly oral Boniva 150 mg or once-weekly oral Fosamax 70 mg for 12months. They also received vitamin D and calcium supplements. The primaryendpoints were the relative change (%) from baseline in average BMD of thelumbar spine and the total hip after 12 months of treatment. Clinicaldifference between the two groups was defined as BMD changes of greater thanor equal to 1.41% for lumbar spine and greater than or equal to 0.87% fortotal hip.

The primary efficacy analysis was based on the per protocol population. By12 months, increase in average lumbar spine BMD was 5.10% among those takingBoniva and 5.78% among those taking Fosamax. Increase in average total hip BMDwas 2.94% and 3.03%, respectively. In addition, treatment with Boniva versusFosamax 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 olderadults. However, fracture was not an efficacy endpoint in the trial.

In the safety analysis, the overall incidence of adverse events wassimilar between the treatment groups. The most frequently reported adverseevents (reported by at least 5% of women in either treatment group) includedhypertension, dyspepsia, back pain, arthralgia, nasopharyngitis, andinfluenza. Of the serious adverse events, less than 1% per group wereconsidered treatment related.

About Osteoporosis

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

About Once-Monthly Oral Boniva

Boniva is indicated for the treatment and prevention of osteoporo
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