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The U.S. Food and Drug Administration (FDA) has approved the
drug Actonel (generic name, risedronate sodium) to help treat and
prevent
osteoporosis, a degenerative bone disease. In clinical
trials ,
Actonel was shown to improve
bone mineral
density and
reduce the risk of broken bones in post-menopausal women who suffer
from osteoporosis. Unlike some of the other drugs used to treat
osteoporosis, actonel is not a
hormone and does not provide the
benefits or risks of estrogen or progestin. Actonel, like Fosamax
(generic name, alendronate) belongs to a group of drugs called
bisphosphonates.
In a study conducted at the University of California at San
Francisco prior to FDA approval, 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 (inactive
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%.
Patients are usually prescribed five milligrams of Actonel
daily. Like Fosamax, Actonel is typically taken
in the morning while in an upright position (sitting or standing)
before the patient has had any food or drink, except plain water.
Patients should not eat or drink anything except plain water for 30
minutes after taking Actonel.
Though side effects of Actonel are generally mild, physicians
do not recommend that patients 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 or infections. As with other drug therapies used to treat
osteoporosis, patients who take Actonel should ask their physician
about also taking daily calcium and vitamin supplements.
Actonel is effective against osteoporosis, 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.
In addition to treating and preventing osteoporosis, Actonel
is also FDA approved to treat Paget’s disease of the bone, a
debilitating bone disease of unknown cause. Actonel is marketed by
Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals
Inc. With an aging population, analysts expect the overall market
for treating osteoporosis to double by 2005. However, physicians say
that the majority of women and men with osteoporosis still go
undiagnosed.
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