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Study compares weekly dosing efficacies of Fosamax and Actonel.

Pharma Business Week

| October 18, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 OCT 18 - (NewsRx.com & NewsRx.net) -- Fosamax Once Weekly (alendronate sodium) increased bone mineral density (BMD) more than Actonel Once-a-Week (risedronate) with similar tolerability, according to results of the Fosamax Actonel Comparison Trial (FACT) .

This is the first U.S. head-to-head study comparing U.S. Food and Drug Administration-approved once-weekly osteoporosis treatments in postmenopausal women with osteoporosis.

In this study, Fosamax provided greater increases in BMD at all sites measured as early as 6 months, and lowered levels of biochemical markers of bone turnover further within the normal pre-menopausal range than Actonel within 3 months. Reducing and stabilizing bone turnover, which leads to increased bone density, are important factors in improving bone strength in patients with osteoporosis.

The results of FACT, which was a 12-month study, were announced online on September 28, 2004, in the Journal of Bone and Mineral Research and were presented on October 1, 2004, at the American Society for Bone Mineral Research meeting in Seattle, Washington. A 12-month extension of this double-blind study, and a second similarly designed study, are currently underway.

Fosamax is the only medicine approved by the U.S. Food and Drug Administration for the treatment of osteoporosis to reduce the risk of both spine and hip fractures in postmenopausal women. Fosamax is the most prescribed medicine for the treatment of osteoporosis, according to Merck, which makes the drug.

"In this 12 month study, Fosamax demonstrated greater increases in BMD and reductions in bone turnover and similar tolerability compared to Actonel," said Marc Hochberg, MD, professor of medicine and epidemiology and Preventive Medicine at the University of Maryland-School of Medicine in Baltimore. "Studies like FACT, that make direct 'head-to-head' comparisons between treatments, are important because they provide important information to clinicians for use in making treatment decisions for postmenopausal women with osteoporosis."

Fosamax showed greater increases in BMD at all pre-specified study endpoints compared to Actonel. Study results showed that Fosamax increased BMD 62% more than Actonel at the hip trochanter, a specific region of the hip, at 12 months (3.4% increase for Fosamax vs. 2.1% for ...

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Source: HighBeam Research, Study compares weekly dosing efficacies of Fosamax and Actonel.

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