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| |  ASBMR: Risedronate’s Benefit Sustained Over Five Years By Jill Stein Special to DG News PHOENIX, AZ -- October 15, 2001 -- Risedronate (Actonel, Optinate) treatment over five years provides a significant sustained prevention of vertebral and non-vertebral fractures in women with postmenopausal osteoporosis. The results, from the first placebo-controlled extension studies of a bisphosphonate, were reported yesterday (Oct. 14) at the 23rd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), in Phoenix, Arizona. Dr. Nelson B. Watts, with the University of Cincinnati, United States, and colleagues elsewhere, evaluated the efficacy and safety of long-term risedronate use over five years by extending two large, three-year fracture efficacy trials - the Vertebral Efficacy with Risedronate Therapy-Multinational (VERT-MN) study and the Vertebral Efficacy with Risedronate Therapy - North America (VERT-NA) study for two years. In the original studies, patients were assigned to risedronate 5 mg/day or placebo. All subjects received 1,000 mg of elemental calcium and up to 500 IU of vitamin D if their baseline levels were low. In the VERT-NA extension, 86 patients who participated in the bone biopsy cohort of the original three-year study agreed to continue for two additional years. In VERT-MN, a total of 265 patients continued their initially assigned treatments in years 4 and 5. Results showed a statistically significant 49 percent reduction in vertebral fracture risk. The risk reduction in non-vertebral fracture associated with risedronate over this period was 37 percent. The rate of adverse events was similar in the risedronate and placebo groups. In the extension period of VERT-NA, bone mineral density was either maintained or continued to increase. On biopsy, normal lamellar bone was observed after five years of risedronate treatment without any pathological findings. Dr. Watts said the results indicate that risedronate treatment over five years provides sustained efficacy and safety as evidenced by an absence of pathological abnormalities on histological examination. Notably, he added, clinical extension trials involving bisphosphonates have usually been open-label continuations of three-year trials.
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