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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

HONOLULU, Sept. 19 /PRNewswire/ -- Women with postmenopausal osteoporosis receiving once-monthly Boniva(R) (ibandronate sodium) achieved clinically comparable increases in bone mineral density (BMD) to those receiving once-weekly Fosamax(R) (alendronate sodium), according to a new study presented at the 29th Annual Meeting of the American Society for Bone and Mineral Research.

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 o
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SOURCE Roche and GSK
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