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ASBMR: Risedronate Shows Significant Early Benefit in Vertebral Fracture Reduction By Jill Stein Special to DG News PHOENIX, AZ -- October 15, 2001 -- Treatment with the pyridinyl bisphosphonate risedronate (Actonel, Optinate) significantly reduces the clinical vertebral fracture rate in women with postmenopausal osteoporosis as early as six months. Dr. Nelson Watts, with the University of Cincinnati in Cincinnati, United States, presented the findings yesterday (Oct. 14) at the 23rd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), in Phoenix, Arizona. Dr. Watts and colleagues evaluated the efficacy of risedronate in decreasing the risk of clinical (ie. symptomatic) vertebral fractures using patients drawn from two large multicenter, randomized, placebo-controlled trials in postmenopausal women. Postmenopausal women who were 85 years of age or younger were enrolled based on either lumbar spine bone mineral density and prevalent vertebral fractures (2,458 patients from the Vertebral Efficacy with Risedronate Therapy-North America (VERT-NA)) or on prevalent vertebral fractures alone (1,226 patients from VERT-Multinational -(MN). All subjects were randomized to one of three groups: risedronate 2.5 mg/day; 5 mg/day; or placebo. In addition, calcium supplementation was provided at 1,000 mg/day and vitamin D 500 IU, if baseline levels were low. The risedronate and placebo groups were similar with respect to age, time since menopause, mean lumbar spine T-score, and mean number of prevalent fractures at the time of enrollment. At six months, clinical vertebral fracture risk was 1 percent in the placebo group and 0.1 percent in the risedronate 5 mg/day group. The difference between the two groups was statistically significant. "It is important to intervene as early as possible in patients at risk for fracture in order to thwart the fracture cascade that often occurs," Dr. Watts advised. Vertebral fractures are associated with increased morbidity and mortality as well as an increased risk of future vertebral and non-vertebral fractures. Vertebral fractures are the most common fractures in osteoporotic patients. Risedronate has been shown to significantly reduce radiographically-confirmed vertebral fractures by 65 percent in VERT-NA and 61 percent in VERT-MN within one year and can be associated with chronic pain and disability. Clinical vertebral fractures account for only one-third of all vertebral fractures. E-mail this page to a friend or colleague! To print, use this version