Effect of Risedronate on the Risk of Hip Fracture in Elderly Women
Michael R. McClung, M.D., Piet Geusens, M.D., Paul D. Miller, M.D., Hartmut Zippel, M.D., William G. Bensen, M.D., Christian Roux, M.D., Ph.D., Silvano Adami, M.D., Ignac Fogelman, M.D., Terrence Diamond, M.D., Richard Eastell, M.D., Pierre J. Meunier, M.D., Richard D. Wasnich, M.D., Maria Greenwald, M.D., Jean-Marc Kaufman, M.D., Ph.D. Charles H. Chesnut, M.D., and Jean-Yves Reginster, M.D., Ph.D.
Background Risedronate increases bone mineral density in elderlywomen, but whether it prevents hip fracture is not known.
Methods We studied 5445 women 70 to 79 years old who had osteoporosis(indicated by a T score for bone mineral density at the femoralneck that was more than 4 SD below the mean peak value in youngadults [–4] or lower than –3 plus a nonskeletalrisk factor for hip fracture, such as poor gait or a propensityto fall) and 3886 women at least 80 years old who had at leastone nonskeletal risk factor for hip fracture or low bone mineraldensity at the femoral neck (T score, lower than –4 orlower than –3 plus a hip-axis length of 11.1 cm or greater).The women were randomly assigned to receive treatment with oralrisedronate (2.5 or 5.0 mg daily) or placebo for three years.The primary end point was the occurrence of hip fracture.
Results Overall, the incidence of hip fracture among all thewomen assigned to risedronate was 2.8 percent, as compared with3.9 percent among those assigned to placebo (relative risk,0.7; 95 percent confidence interval, 0.6 to 0.9; P=0.02). Inthe group of women with osteoporosis (those 70 to 79 years old),the incidence of hip fracture among those assigned to risedronatewas 1.9 percent, as compared with 3.2 percent among those assignedto placebo (relative risk, 0.6; 95 percent confidence interval,0.4 to 0.9; P=0.009). In the group of women selected primarilyon the basis of nonskeletal risk factors (those at least 80years of age), the incidence of hip fracture was 4.2 percentamong those assigned to risedronate and 5.1 percent among thoseassigned to placebo (P=0.35).
Conclusions Risedronate significantly reduces the risk of hipfracture among elderly women with confirmed osteoporosis butnot among elderly women selected primarily on the basis of riskfactors other than low bone mineral density.
Source Information
From the Oregon Osteoporosis Center and Providence Medical Center, Portland (M.R.M.); Limburg University Center, Diepenbeek, Belgium, and the University of Maastricht, Maastricht, the Netherlands (P.G.); Colorado Center for Bone Research, Lakewood (P.D.M.); Humboldt Universität Berlin Charité, Berlin, Germany (H.Z.); St. Joseph's Hospital, McMaster University, Hamilton, Ont., Canada (W.G.B.); Hôpital Cochin, Paris (C.R.); Centro Ospedaliero, Clinicizzato di Valeggio, Valeggio, Italy (S.A.); Guy's Hospital, London (I.F.); St. George Hospital, Kogarah, N.S.W., Australia (T.D.); the University of Sheffield, Sheffield, United Kingdom (R.E.); Edouard Herriot Hôpital, Lyons, France (P.J.M.); Hawaii Osteoporosis Center, Honolulu, Hawaii (R.D.W.); Osteoporosis Medical center, Palm Springs, Calif. (M.G.); Universitair Ziekenhuis, Ghent, Belgium (J.-M.K.); University of Washington, Seattle, Wash. (C.H.C.); and the University of Liège, Liège, Belgium (J.-Y.R.).
Address reprint requests to Dr. McClung at the Oregon Osteoporosis Center, 5050 N.E. Hoyt, Suite 651, Portland, OR 97213, or at mmcclung{at}oregonosteoporosis.com.
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