New Osteoporosis Medication Approved by FDA

Injectable Drug Prolia Reduces Fractures in Postmenopausal Women

The Food and Drug Administration recently approved the drug Prolia (denosumab) for use in treating osteoporosis in postmenopausal women. According to the National Institutes of Health, nearly 50 percent of women over age fifty will experience a bone fracture caused in some part by osteoporosis. Prolia is designed to prevent fractures by promoting bone strength, while also providing a convenient alternative to the most common osteoporosis treatment options currently prescribed.

In the three-year clinical trial testing the efficacy of the drug at reducing vertebral fractures, which observed nearly 8,000 postmenopausal women with osteoporosis, the injected medicine was shown to help reduce vertebral fractures by 68 percent. The women treated with Prolia had a 2 percent incidence of spine fracture compared to a 7 percent incidence in women in the placebo group. The manufacturer had claimed the drug would be more effective than the current medications, but the results are similar to the success rates of the current drugs on the market. One benefit shown in this clinical trial was an increased prevention of fractures in other parts of the body by about 25 percent overall, and by about 40 percent in the hip.

Unlike the most common osteoporosis treatments currently on the market, Prolia is injected by a doctor every 6 months. Most current treatments deliver medication daily through pills or weekly through skin patches. The physician supervised injection method of treatment is designed to ensure patients do not miss any daily doses and to be more convenient than a daily or weekly regimen.

Prolia, manufactured by Amgen, is the first biologic injectable medication to be approved by the FDA for the treatment of osteoporosis. There currently are synthetic injectable medications on the market for treating osteoporosis, including Reclast and Forteo. Biologic medications are not synthetic chemicals, but are genetically engineered versions of human proteins, which are also used to treat conditions such as rheumatoid arthritis and psoriasis. Prolia will offer a treatment possibility for the population of patients who cannot be treated with the synthetic medications due to allergic reactions, side effects, or patients with weak kidney function.

The current risk of taking Prolia is that the drug has not been tested on a large scale yet and indications of a side effect reaction are not fully known. Side effects similar to the synthetic osteoporosis medications are osteocronosis of the jaw, back and leg pain, and muscle pain. Additional side effects reported were skin infections and higher cholesterol levels. As such, the FDA will require patients who are considering Prolia to receive a guide that explains the risks of the drug. The drug works by preventing the breakdown and re-absorption of bone and calcium, thereby letting bone growth catch up to bone loss. Because there is less absorption of Calcium from bones, supplements of Vitamin D and Calcium should be taken in conjunction with this medication.

Prolia is now commercially available and is also being tested as a treatment for bone loss from cancer treatments.

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