According to a new study, postmenopausal women with osteoporosis who received 5 mg daily of Actonel (risedronate) experienced a 70 percent reduction in the risk of moderate and severe vertebral fracture within one year of treatment. The study also showed that this risk reduction benefit was maintained through three years of treatment.
The study, presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR), included data from two large trials (VERT-NA, a multinational study, and VERT-MN, a North American study) involving postmenopausal women with one prevalent vertebral fracture and low bone mineral density (BMD), or two prevalent vertebral fractures, who were treated with either risedronate 5 mg daily or a placebo.
In the combined VERT studies, a total of 1,994 postmenopausal women with osteoporosis were randomized to receive either risedronate 5 mg daily or a matched placebo. All patients received 1 g per day of calcium supplementation and up to 500 I.U. vitamin D per day if serum levels were low at baseline. During the first year, only 1.4 percent of patients in the risedronate-treated group experienced a new moderate or severe vertebral fracture compared to 4.6 percent in the placebo group. In risedronate treated patients, the risk reduction in moderate and severe vertebral fractures at one year was 70.7 percent.
Recent studies have shown that the severity of prevalent vertebral fractures is a predictor of future vertebral and non-vertebral fracture risk; patients with more severe baseline vertebral fractures are more likely to experience subsequent vertebral and non-vertebral fractures. Therefore, rapidly reducing the risk of moderate or severe vertebral fractures can help decrease the risk of future fractures.
Osteoporosis affects more women than heart attack, stroke and breast cancer combined. An osteoporotic fracture occurs every 30 seconds in the European Union, and every 20 seconds in the United States. One out of every five women with postmenopausal osteoporosis who have experienced a vertebral fracture will fracture again within just one year, potentially leading to a fracture cascade.
Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg once-a-week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment for chronic diseases.