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New Drug, Actonel, Reduces Bone Fractures in Post-Menopausal Women

A new drug called Actonel (generic name, risedronate sodium) has been shown to improve bone mineral density and reduce the risk of broken bones in post-menopausal women who suffer from osteoporosis.  A study published in the October 13, 1999 issue of the Journal of the American Medical Association reveals women who take five milligrams of Actonel daily may significantly reduce their risk of spinal, wrist, and hip fractures.

In a study conducted at the University of California at San Francisco, researchers observed 2,500 post-menopausal woman between 1993 and 1998. In 450 women who were given Actonel, the risk of spinal fractures was reduced by 41% after three years compared with those who were given a placebo (ineffective pill). Actonel was also shown to reduce the frequency of wrist and hip fractures by 39%.

A previous clinical trial that enrolled 4,875 post-menopausal women with osteoporosis, showed that taking Actonel reduced the incidence of spinal fractures by almost 50%. Actonel is currently approved by the U.S. Food and Drug Administration (FDA) to treat Paget’s disease of the bone—a debilitating bone disease of unknown cause. In late 1999, Actonel was submitted to the FDA for approval to treat osteoporosis. A spokesperson for Proctor and Gamble, the manufacturer of Actonel, says the company expects FDA approval to come early in the year 2000.

If approved by the FDA, Actonel will join a handful of other drugs used to fight bone loss, including raloxifene, alendronate sodium , and calcitonin. Since women will have different responses to different therapies, researchers hope the addition of Actonel will help treat more women with osteoporosis.

Though side effects of Actonel were mild in clinical trials, physicians do not recommend that women with severe kidney disorders or stomach or digestive problems take Actonel. The most common side effects of Actonel noted in clinical trials were indigestion, nausea and abdominal pain. Other side effects may include allergic reactions, difficulty swallowing, heartburn, or a burning sensation under the ribs. As with other drug therapies used to treat osteoporosis, woman who take Actonel should also take daily calcium and vitamin supplements.

Osteoporosis is a degenerative bone disease that primarily affects post-menopausal women. It is estimated that one-third of women over age 50 have osteoporosis. Osteoporosis affects roughly 25 million Americans and is currently one of the most under-diagnosed and under-treated disorders in medicine.

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