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Risedronate Prevents New Vertebral Fractures in Postmenopausal Women at High Risk

University of Cincinnati (N.B.W.), Cincinnati, Ohio 45219; St. Michael’s Hospital (R.G.J.), University of Toronto, Toronto, Ontario, Canada M5C 2T2; East Tennessee State University (R.C.H.), Johnson City, Tennessee 37614; St. Peter’s Hospital (R.A.H.), Chertsey KT16 0PZ, United Kingdom; Procter & Gamble Pharmaceuticals (M.D.M., I.B.), Mason, Ohio 45040; Medical Diagnostics Australia (D.C.), Sydney 2204, Australia; Free University Berlin, University Hospital Benjamin Franklin (D.F.), Centre of Muscle and Bone Research, 12200 Berlin, Germany

Address all correspondence and requests for reprints to: Nelson B. Watts, M.D., 222 Piedmont Avenue, Suite 4300, Cincinnati, Ohio 45219. E-mail: nelson.watts{at}uc.edu.

Independent risk factors for fracture include advanced age, preexisting fractures, and low bone mineral density. Rised-ronate has been shown in several large trials to be safe and effective for patients with osteoporosis, but its effects in populations at high risk are not well characterized. To determine the effect of risedronate on vertebral fracture in high-risk subjects, we pooled data from two randomized, double-blind studies [Vertebral Efficacy with Risedronate Therapy (VERT) Multinational (VERT-MN) and VERT-North America (VERT-NA)] in 3684 postmenopausal osteoporotic women treated with placebo or risedronate 2.5 or 5 mg/d and analyzed fracture risk in subgroups of subjects at high risk for fracture due to greater age or more prevalent fractures (vs. median for overall study population), or lower bone mineral density (T-score, -2.5 or less). Fractures were diagnosed by quantitative and semiquantitative assessment of radiographs at baseline and 1 yr. In the overall population, treatment for 1 yr with risedronate 5 mg/d reduced the risk of new vertebral fractures by 62% vs. control (relative risk, 0.38; 95% confidence interval, 0.25, 0.56; P < 0.001) and of multiple new vertebral fractures by 90% vs. control (relative risk, 0.10; 95% confidence interval, 0.04, 0.26; P < 0.001). Consistent risk reductions were observed at 1 yr in the risedronate-treated high-risk subgroups. Significant reduction in fracture risk after 1 yr is an important benefit in patients at high risk for fracture because, without treatment, these patients are likely to sustain new fractures in the near term.

This work was supported by Procter \|[amp ]\| Gamble Pharmaceuticals (Mason, OH) and Aventis Pharma (Bridgewater, NJ).

Members of the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group: J. Adachi, Hamilton, Ontario, Canada; S. Adami, Centro Ospedaliero, Valeggio, Italy; R. Altman, Miami, FL; D. J. Appelrouth, Atlanta, GA; J. Assini, Schenectady, NY; A. D. Bankhurst, University of New Mexico School of Medicine, Albuquerque, NM; M. Baron, Jewish General Hospital, Montreal, Quebec, Canada; D. J. Baylink, Loma Linda, CA; H. Beck-Nielsen, Odense University Hospital, Odense C, Denmark; N. H. Bell, VA Medical Center, Charleston, SC; W. Bensen, Hamilton, Ontario, Canada; M. B. Block, Clinical Research Center, Phoenix, AZ; R. S. Bockman, New York, NY; E. Boling, Rancho Cucamonga, CA; M. Bolognese, Gaithersburg, MD; S. L. Bonnick, Center for Research on Women’s Health, Denton, TX; S. Bowman, Tampa Bay Medical Research, Clearwater, FL; M. L. Brandi, Universitá di Firenze, Firenze, Italy; B. Bresnihan, St. Vincent’s Private Hospital, Dublin, Ireland; W. Briney, Denver, CO; J. Brown, Le Center Hospitalier de l’Universite Laval, Sainte-Foy, Quebec, Canada; S. B. Broy, Lutheran General Medical Group, Chicago, IL; R. Burwood, Sussex Diagnostic Centre, Hove, UK; J. Cabral, Cleveland Clinic Florida, Ft. Lauderdale, FL; D. Cameron, Princess Alexandra Hospital, Woolloongabba, Australia; R. B. Cannon, Salt Lake Clinic Research Foundation, Salt Lake City, UT; M. Cawley, Rheumatology Research Unit, Southampton, UK; C. Chesnut III, University of Washington, Seattle, WA; Y. D. Coble, Jacksonville, FL; S. Cohen, Metroplex Clinical Research Center, Dallas, TX; S. A. Cohen, Clinical Research Consultants, Trumball, CT; G. M. Crawford, Community Pharmacology Services Ltd., Glasgow, UK; M. W. J. Davie, NHS Trust Hospital, Oswestry, UK; J. Davies, Royal National Hospital for Rheumatic Diseases, Bath, UK; M. Davis, Coastal Clinical Research Inc., Mobile, AL; W. Delaney, Primary Care of Danbury, Danbury, CT; M. d’Emden, Royal Brisbane Hospital, Brisbane, Australia; J. Dequeker, Pellenberg, Belgium; J. P. Devogelaer, UCL, Brussels, Belgium; G. B. Dewees, SORRA Research Center, Birmingham, AL; R. Dingler, Munich, Germany; W. Dodds, Lancaster Moor Hospital, Lancaster, UK; S. Doherty, Hull Royal Infirmary, Hull, UK; D. V. Doyle, Silverthorn Centre, Chingford, UK; M. Doyle, William Beaumont Hospital, Ferndale, MI; R. Eastell, University of Sheffield, Sheffield, UK; P. Ebeling, Royal Melbourne Hospital, Parkville, Australia; R. D. Emkey, Reading Hospital and Medical Center, Reading, PA; S. C. English, Deaconess Research Institute, Billings, MT; M. P. Ettinger, Regional Osteoporosis Center, Stuart, FL; A. Fairney, St. Mary’s Hospital Medical School, London, UK; J. Farrerons, Hospital Santa Creu y Sant Pau, Barcelona, Spain; N. R. Farris, Central Kentucky Research, Lexington, KY; A. Frank, Northwick Park Hospital, Harrow, UK; B. Fraser, Royal Liverpool University Hospital, Liverpool, UK; D. Freeman, North Carolina Arthritis & Allergy Care Center, Raleigh, NC; N. M. Friedman, Lovelace Scientific Resources, Albuquerque, NM; A. B. Galway, Health Science Center, St. Johns, New Brunswick, Canada; M. L. S. Gass, Reproductive Medical Research, Cincinnati, OH; H. Geisberg, Anderson, SC; H. K. Genant, University of California, San Francisco, CA; C. Gennari, Universitá deglie Studi di Siena, Siena, Italy; G. Gerety, Albany, NY; P. Geusens, Dr. Willems Instituut, Diepenbeek, Belgium; J. Ginsburg, Royal Free Hospital, London, UK; M. Gittelman, South Florida Medical Research, Aventura, FL; M. Greenwald, Palm Springs, CA; T. N. Hangartner, Miami Valley Hospital, Dayton, OH; D. A. Hanley, Heritage Medical Research Center, Calgary, Alberta, Canada; T. Harrington, Jackson Foundation, Madison, WI; S. T. Harris, University of California, San Francisco, CA; D. J. Helfrich, Mercy Hospital of Pittsburgh, Pittsburgh, PA; M. Heller, Arthritis Associates Inc., Peabody, MA; M. Heur, The Climacteric Clinic, Gainesville, FL; M. C. Hochberg, University of Maryland, Baltimore, MD; A. Hodsman, St. Joseph’s Health Center, London, Ontario, Canada; M. Hooper, Repatriation General Hospital, Concord, Australia; D. Hosking, Nottingham City Hospital and NHS Trust, Nottingham, UK; T. H. Ittel, RWTH Aachen, Aachen, Germany; R. D. Jackson, Columbus, OH; A. J. Jacobs, Arthritis Center of Nebraska, Lincoln, NE; P. Jellinger, Hollywood, FL; O. Johnell, Ortopediska Kliniken, Malmö, Sweden; C. C. Johnston, Jr., Indiana University Medical Center, Indianapolis, IN; A. V. Jovaisas, Ottawa, Ontario, Canada; J. L. Juozevicius, Kalamazoo, MI; R. A. Kaplan, Concord, CA; J. M. Kaufman, U. Z. Gent, Gent, Belgium; M. Keller, San Diego, CA; D. L. Kendler, Vancouver Hospital and Health Science Centre, Vancouver, British Columbia, Canada; R. Khairi, Physicians Research Group, Indianapolis, IN; M. S. Kipnes, DGD Research, San Antonio, TX; A. J. Kivitz, Altoona, PA; J. Kotler, Holy Cross Hospital, Ft. Lauderdale, FL; N. Koval, Arthritis & Rheumatism Associates, Wheaton, MD; N. J. Kramer, Charlotte, NC; A. J. Laster, First Charlotte Physicians, Charlotte, NC; E. Leib, Fletcher Allen Health Center, Burlington, VT; R. M. Levy, Olympia Arthritis Clinic, Olympia, WA; A. A. Licata, Cleveland Clinic Foundation, Cleveland, OH; R. Lies, Wichita Clinic, Wichita, KS; T. Littlejohn, Piedmont Research Associates, Winston-Salem, NC; S. Ljunghall, Medicinska Kliniken, Uppsala, Sweden; R. Lorenc, Memorial Hospital, Warsaw, Poland; M. Lowenstein, Palm Harbor, FL; C. Lozano, Hospital Universitario San Carlos, Madrid, Spain; B. Lund, Copenhagen, Denmark; F. Maggiacomo, Silver Lake Medical Inc., Providence, RI; A. Mangione, Jenkintown, PA; E. Marcinowska- Suchowierska, Postgraduate Medical Center, Warsaw, Poland; R. E. Marcus, Rheumatology Associates of North Jersey, Teaneck, NJ; M. Maricic, University of Arizona Health Sciences Center, Tucson, AZ; M. R. McClung, Osteoporosis Research Center, Portland, OR; H. H. McIlwain, Tampa, FL; C. D. McKeever, Research for Health Inc., Houston, TX; M. J. McKenna, St. Michael’s Hospital, Dublin, Ireland; D. Mellström, Osteroporos kliniken, Göteborg, Sweden; C.-J. Menkes, Hôpital Cochin, Paris, France; P. Miller, Colorado Center for Bone Research, Lakewood, CO; S. S. Miller, San Antonio, TX; M. G. Molloy, Cork Regional Hospital, Cork, Ireland; H. W. Minne, Clinic for Metabolic Bone Disease, Bad Pyrmont, Germany; H. Mulder, Good Clinical Practice, Rotterdam, The Netherlands; A. Mulloy, Medical College of Georgia, Augusta, GA; J. Munoz, Hospital Clinic I Provincial, Barcelona, Spain; J. A. Napier, St. Petersburg, FL; G. Nicholson, The Geelong Hospital, Geelong, Australia; S. P. Nielsen, Hillerød Sygehus, Hillerød, Denmark; G. Nuki, University of Edinburgh, Edinburgh, UK; L. Olanksky, Oklahoma University Health Sciences Center, Oklahoma City, OK; W. Olszynski, Midtown Medical Center, Saskatoon, Saskatchewan, Canada; M. Palmér, Örebro Lasarett, Örebro, Sweden; A. Parsons, University of Warwick, Coventry, UK; S. A. Pasquale, University Hospital, New Brunswick, NJ; D. A. Podlecki, Longmont Clinic, Longmont, CO; B. Pornel, Brussels Menopause Center, Brussels, Belgium; J. J. Prendergast, Pacific Medical Research Services, Atherton, CA; T. Price, Cannock Chase Hospital, Cannock, UK; H. M. Prupas, Reno, NV; J. Przedlacki, Krajowe Centrum Osteoporozy, Warsaw, Poland; S. Quandt, Bowman Gray School of Medicine, Winston-Salem, NC; R. J. Rapoport, Fall River, MA; J.-Y. Reginster, Université de Liège, Liège, Belgium; D. Reid, University of Aberdeen, Aberdeen, UK; A. Roberts, Ashford International Research Centre, Ashford, Australia; J. M. Rodriguez, Hospital de Belvitge, Barcelona, Spain; T. Rooney, Des Moines, IA; C. Rosen, St. Joseph Hospital, Bangor, ME; S. Rosenblatt, Irvine, CA; C. Roux, Hôpital Cochin, Paris, France; J. B. Rubiò, Servicio de Reumatologia Hospital del Mar, Barcelona, Spain; L. G. Ste-Marie, Centre de Recherche Andre-Viallet, Montreal, Quebec, Canada; P. Salmela, Oulu University Central Hospital, Oulu, Finland; J. Salmni, Universitetsjukhuset, Tammerfors, Finland; B. Samuels, Stafford Medical Associates, Dover, NH; A. Z. Sawicki, Warsaw Centre of Osteoporosis and Calcium Metabolism, Warsaw, Poland; E. N. Schwartz, Foundation for Osteoporosis Research & Education, Oakland, CA; S. Scumpia, Center for Clinical Research, Austin, TX; J.-L. Sebert, Hopital Nord, Amiens, France; W. J. Shergy, Rheumatology Association of North Alabama, Huntsville, AL; G. Sigurdsson, Borgarspitalinn, Fossvogi, Iceland; S. L. Silverman, The Osteoporosis Medical Center, Beverly Hills, CA; C. L. Smith, Hennepin County Medical Center, Minneapolis, MN; I. G. Smith, Wrightington Hospital & NHS Trust, Wigan, UK; O. H. Sorensen, Copenhagen Municipal Hospital, Copenhagen, Denmark; J. G. Spiro, Harwell Laboratories, Didcot, UK; J. L. Stock, Clinical Research Office, Worcester, MA; H. Stracke, Medizinische Poliklinik Giessen, Giessen, Germany; H. Taggart, Belfast City Hospital, Belfast, UK; A. Tenenhouse, Clinical Research Group, Montreal, Quebec, Canada; L. Tessari, Istituto Scientifico San Raffaele, Milan, Italy; P. Thompson, Poole Hospital, Poole, UK; W. Tlustockowicz, Centralny Szpital Kliniczny, Warsaw, Poland; G. H. Tomkin, Adelaide Hospital, Dublin, Ireland; M. Välimäki, Third Department of Medicine, Helsingfors, Finland; A. Virshup, West Palm Beach, FL; R. D. Wasnick, Hawaii Osteoporosis Center, Honolulu, HI; N. Wei, Arthritis and Osteoporosis Center of Maryland, Frederick, MD; S. R. Weiss, San Diego, CA; T. J. Wilkin, University of Plymouth, Plymouth, UK; K. W. Woodhouse, University of Wales, Penarth, UK; A. Woolf, Royal Cornwall Hospital, Truro, UK; M. Yeates, Central Coast Radiology, Gosford, Australia; and T. M. Zizic, Baltimore, MD.

Abbreviations: BMD, Bone mineral density; CI, confidence interval; NHANES III, third National Health and Nutrition Examination Survey; RR, relative risk; VERT, Vertebral Efficacy with Risedronate Therapy; VERT-MN, VERT Multinational; VERT-NA, VERT North America.

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