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Once-a-year Drug Reduces Fractures from Osteoporosis

A treatment for osteoporosis delivered once a year is as effective as current monthly or weekly osteoporosis regimens at reducing the incidence of bone fractures, according to a new study led by a UCSF research team.

Results from a three-year, international study of 7,736 postmenopausal women with osteoporosis are reported in the May 3, 2007 issue of the "New England Journal of Medicine." Study findings also are available online at content.nejm.org.

The study showed that treatment with zoledronic acid (marketed as Reclast) was very effective in reducing the incidence of all types of fractures in women with postmenopausal osteoporosis, the researchers said. Impact included a 70 percent reduction in the risk of spinal fractures and a 40 percent reduction in the risk of hip fractures. The effect was sustained over three years.

"The reductions in hip and spine fractures were at least as large as those seen with other drugs in this category," said Dennis Black, PhD, a professor of epidemiology and biostatistics in the UCSF School of Medicine, who led the study. "But even more remarkable were the strong, significant and consistent effects across all fracture types."

Reclast is an investigational drug in the bisphosphonate drug category that is being developed by Novartis Pharmaceuticals Corp., a U.S. affiliate of the Swiss-based Novartis AG. It is the only once-yearly bisphosphonate treatment being studied for osteoporosis and is still in the approval process through the Food and Drug Administration.

Three other drugs in the bisphosphonate family (marketed as Fosamax, Actonel and Boniva) are currently available and most commonly used as a once per week or once per month pill.

"For the first time, women could have the option of being treated once a year for osteoporosis, instead of having to remember to take a weekly pill," Black said. "Adherence to these weekly and monthly regimens is of
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