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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.
Additional Resources and
References
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