Treat Osteoporosis Twice a Year with Prolia

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Jun 2 2010 - 10:49am

Postmenopausal women who have osteoporosis now have another treatment option, and this one requires an injection only twice a year. The Food and Drug Administration (FDA) has just approved Prolia (denosumab), which is for postmenopausal women at high risk for fractures due to osteoporosis.

Currently, medications for postmenopausal women with osteoporosis include several bisphosphonates that require various dosing options. Alendronate (Fosomax) has both daily and weekly forms, while ibandronate (Boniva) can be taken once monthly for prevention or treatment or every three months intravenously for treatment. Risedronate (Actonel) has daily, weekly, and twice-monthly forms, and zoledronic acid (Reclast) is available intravenously in a once yearly dose that requires two blood tests prior to dosing.

Prolia is not a bisphosphonate, but a human monoclonal antibody and an injectable medication that is recommended once every six months. In the latest study leading up to its approval, Prolia was evaluated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. Results showed Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in the study participants.

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Prolia use was associated with a variety of side effects, the most common ones being back pain, musculoskeletal pain, elevated cholesterol, pain in the extremities, and urinary bladder infections. More serious reactions included low calcium levels in the blood (hypocalcaemia), serious infections (including skin infections), and skin reactions such as eczema and rash.

Julie Beitz, MD, director of the FDA’s Office of Drug Evaluation III noted that “the approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.” Fractures are a major health challenge in the United States, with half of women older than 50 experiencing a fracture related to osteoporosis.

Prolia works by decreasing the deterioration of bone, suppressing bone turnover, and increasing bone strength and mass. A possible complication of this suppression is a serious bone disease called osteonecrosis of the jaw, atypical fractures, and delayed healing of fractures. Use of bisphosphonates is also associated with rare reports of osteonecrosis, according to the National Osteoporosis Foundation.

Approval of Prolia offers postmenopausal women who have osteoporosis another treatment option, one that requires dosing twice a year. Approximately 80 percent of the 10 million individuals in the United States who have osteoporosis are women, according to the National Osteoporosis Foundation. Nearly 34 million more people are estimated to have low bone mass, placing them at increased risk for osteoporosis.

SOURCES:
Food and Drug Administration
National Osteoporosis Foundation

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