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FDA Approved Drug – Prolia – for Post-Menopausal Women

 
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Osteoporosis is a debilitating disease that affects countless numbers of women, especially during the postmenopausal years. As the disease progresses and causes one’s bones to become weak and brittle, the bones are more likely to fracture, especially in the hips, spine, and wrists. As such, leading a normal, healthy, and independent life can be a challenge. However, the face of that challenge is about to change.

Thanks to a new drug that has been approved by the U.S. Food and Drug Administration and has made its debut in the U.S., postmenopausal women with osteoporosis can now obtain a twice-yearly injection designed to reduce the risk of fracture.

According to WebMD health news, Prolia is approved only for specific types of patients:

*Postmenopausal women with osteoporosis and high risk of fracture (that is, previous fracture due to osteoporosis or multiple fracture risk factors)

*Patients with osteoporosis for whom other osteoporosis treatments have failed.

*Patients who cannot tolerate other osteoporosis treatments.

Administered by a health care provider, Prolia is given every six months as an injection right under the skin. Generically known as Denosumab, Prolia is the first new class of medicine introduced in nearly a decade to treat postmenopausal osteoporosis (PMO). PMO is one of the most common diseases and will continue to become more common as our population ages and increases. Prolia can reduce the risk of fracture in the spine, hip, and other areas of the body.

Amgen, a leading biotechnology company in Thousand Oaks, California, has been a pioneer in bringing new medicines from the lab, to the manufacturer and on to the patient. The scientists at Amgen have spent the last 15 years working towards a discovery of a pathway that regulates the metabolism in the bone, and as a result, Prolia was discovered. This is an important new medicine for those women with osteoporosis who are at a high risk for fractures.

In a three-year study that involved 7,808 postmenopausal women ages 60 to 91 with osteoporosis, the injections of Prolia resulted in stronger bones, increased bone density, and a reduced risk for fractures associated with osteoporosis. The U.S. government statistics report that about 80 percent of those with osteoporosis are female, and about half of women age 50 or older will incur a fracture related to osteoporosis at some time in their lives.

The availability of this new drug in the United States was announced at the beginning of June 2010. Part two of this report will focus on the benefits and the side effects of Prolia.

(Certain information for this article was obtained at http://www.medicinenet.com/script/main/art.asp?articlekey=116809)

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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