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| |  DG DISPATCH - WCO: Actonel (Risedronate) Effectively Prevents Spinal Fractures By W. A. Thomasson, PhD Special to DG News
CHICAGO, IL -- June 19, 2000 -- Actonel (risedronate) effectively prevents osteoporosis-induced fracture of the spine, according to combined data from five studies presented Sunday (June 18) at the World Congress on Osteoporosis. Rich Eastell, MD, of Sheffield, United Kingdom said the data are consistent across all studies, even though subjects were recruited using a wide variety of criteria. The five studies include two large ones in which vertebral fracture was the primary end point -- VERT-NA in North America and VERT-MN in Europe and Australasia; a third large study in which the primary end point was hip fracture (HIP); and two studies in patients using oral glucocorticoids (CRP and CRT; Actonel treatment was begun simultaneously with glucocorticoids in CRP and some time later in CRT). Data on the HIP study were reported for the first time at the Congress. The HIP study enrolled more than 9,000 post-menopausal women. Those younger than age 80 years were required to have a femoral neck bone mineral density (BMD) T-score of below -3 plus a clinical risk factor for hip fracture. Those over age 80 years required only clinical risk factors. The results show that, at the end of the three-year study, Actonel treatment reduced vertebral fractures by 30 percent. In addition, there was a 55 percent reduction by the end of the first year of treatment. The hip fracture data were presented on Saturday by Mike McClung, MD, of Portland, OR. They showed a highly significant reduction of hip fracture in patients with demonstrated osteoporosis, but not in those entered on the basis of clinical risk factors alone. Patients in the two VERT studies either had experienced two previous vertebral fractures or had experienced one vertebral fracture and had a T-score of less than -2. In these high-risk patients, the one-year reduction in fracture risk was greater than 60 percent. In combined results from the two CR studies, where patients -- some relatively young -- were enrolled on the basis of current glucocorticoid use, the reduction in fracture risk was 70 percent. "I think it is safe to conclude that when one looks at a wide variety of patients at risk of fracture, you do see a consistent effect [with Actonel]," Dr. Eastell said.
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