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Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study

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Abstract

Summary

In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated.

Introduction

This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years.

Methods

A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N = 7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers.

Results

At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P < 0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n = 1,324; femoral neck T-score ≤−3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P = 0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P < 0.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P < 0.05) and was generally safe and well tolerated.

Conclusions

The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.

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Acknowledgments

This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc in October 2009. The authors thank Monika Ciesielska for statistical analysis. Medical writing assistance for this manuscript was provided by Bo Choi, Ph.D., of MedErgy and was funded by Pfizer Inc.

Conflicts of interest

Dr. Silverman has served on advisory boards for Wyeth and Lilly and on the speakers bureau for Lilly. Dr. Kendler has served as a consultant/speaker for and has received research grants from Amgen, Biosante, Eli Lilly, GSK, Merck, Novartis, Nycomed, Pfizer, Procter & Gamble, Roche, Servier, Wyeth, and Zelos. Dr. Kung has served as an advisory board member/consultant/speaker for Eli Lilly, GSK, Merck, MSD (Asia Ltd), Procter & Gamble, Roche, sanofi-aventis, and Servier. Dr. Felsenberg has served as a consultant/speaker for Amgen, Bayer/Schering, Chugai, Eli Lilly, GSK, Merck/MSD, Novartis, Nycomed, Procter & Gamble, Roche, Servier, TEVA, and Wyeth. Dr. Adachi has served as a consultant/speaker for Amgen, Astra Zeneca, Eli Lilly, GSK, Merck, Novartis, Nycomed, Pfizer, Procter & Gamble, Roche, sanofi-aventis, Servier, Wyeth, and Bristol-Myers Squibb. Drs. Constantine, Mairon, and Chines were employees of Wyeth Research, which was acquired by Pfizer Inc in October 2009. All other authors report no conflicts of interest.

All authors had full and unrestricted access to the study data. Drs. Silverman, Kendler, Kung, Teglbjærg, Felsenberg, and Adachi served as principal investigators in the study (see “Appendix”). They, along with Drs. Constantine, Mairon, and Chines, analyzed and interpreted data, were involved in the development/critical revision of the manuscript, and approved the final version submitted.

Author information

Authors and Affiliations

  1. Cedars-Sinai Medical Center and University of California, Los Angeles, CA, USA

    S. L. Silverman

  2. Pfizer Inc, Collegeville, PA, USA

    A. A. Chines & G. D. Constantine

  3. Prohealth Research, University of British Columbia, Vancouver, British Columbia, Canada

    D. L. Kendler

  4. Department of Medicine, The University of Hong Kong, Hong Kong, China

    A. W. C. Kung

  5. Center for Clinical and Basic Research, Ballerup, Denmark

    C. S. Teglbjærg

  6. Center of Muscle and Bone Research, Charité University Medicine Berlin, Free University and Humboldt University, Berlin, Germany

    D. Felsenberg

  7. Wyeth Pharmaceuticals, Paris, France

    N. Mairon

  8. St. Joseph’s Healthcare, McMaster University, Hamilton, Ontario, Canada

    J. D. Adachi

  9. OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Beverly Hills, CA, 90211, USA

    S. L. Silverman

Authors
  1. S. L. Silverman
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  2. A. A. Chines
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  4. A. W. C. Kung
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  5. C. S. Teglbjærg
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  6. D. Felsenberg
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  7. N. Mairon
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  8. G. D. Constantine
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  9. J. D. Adachi
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Consortia

for the Bazedoxifene Study Group

Corresponding author

Correspondence to S. L. Silverman.

Additional information

N. Mairon and G. Constantine are no longer affiliated with Wyeth/Pfizer.

Appendix

Appendix

In addition to Drs. Silverman, Kendler, Kung, Teglbjærg, Felsenberg, and Adachi, the following were principal investigators: Argentina: Jose Ruben Zanchetta, Instituto de Investigaciones Metabolicas, Buenos Aires. Australia: Rodney Baber, North Shore Private Hospital, St. Leonards, NSW; Michael Hooper, Concord Hospital, Concord; Jane Howard, Royal Women’s Hospital, Herston; Sheila O’Neil, Royal Women’s Hospital, Herston; Richard Prince, Sir Charles Gairdner Hospital, Nedlands; Anthony Roberts, South Australian Endocrine Clinical Research, Ashford; Bronwyn Stuckey, KEOGH Institute for Medical Research, Nedlands. Belgium: Piet Geusens, Biomedical Research Institute, Diepenbeek; J. M. Kaufmann, University Hospital, Gent. Brazil: Marco Aurelio Albernaz, Instituto medico Coracoralina, Goiania; Cesar Fernandes, ISBEM, Sao Paulo; Alberto Soares Pereira Filho, Hospital General da Santa Casa, Rio de Janiero; Sebastiao Medieros, Clinica Femino, Mato Grasso; Jose Carlos Menegoci, Clinica Sao Francisco, San Paulo; Luis Augusto Tavares Russo, CCBR Brasil, Rio de Janeiro. Bulgaria: Anna Maria Borissova, Specialized Hospital for Active Treatment on Endocrinology, Nephrology and Gerontology, Sofia; Mihail Boyanov, Multifunctional Hospital for Active Treatment, Sofia; Pencho Delev, Multifunctional Hospital for Active Treatment, Plovdiv; Stefka Kuzmanova, Multifunctional Hospital for Active Treatment, Plovdiv; Rumen Lubenov, Specialized Hospital for Active Treatment of Gynaecology and Obstetrics, Sofia; Plamen Popivanov, Multifunctional Hospital for Active Treatment, Sofia; Todor Russev, Multiprofile Hospital for Active Treatment, Pleven; Yordan Sheitanov, Multifunctional Hospital for Active Treatment, Sofia; Mihail Ventzeslavov Protich, Multifunctional Hospital for Active Treatment, Sofia; Nataliva Temelkova, Multifunctional Hospital for Active Treatment, Sofia. Canada: Jacques Brown, Group de Recherché en Rhumatologie et Maladies Osseuses, Ste-Foy, Quebec; Ian Campbell, Kells Medical Research Group Inc., Pointe-Claire, Quebec; Denis Choquette, Institut de rhumatologie de Montreal, Montreal, Quebec; Monique Drapeau, Q&T Recherche Inc., Sherbrooke, Quebec; Michel Fortier, Clinique RSF Inc., Quebec, Quebec; David Hanley, Heritage Medical Research Clinic, Calgary, Alberta; Anthony B. Hodsman, St. Joseph’s Healthcare, London, Ontario; Robert Josse, St. Michael’s Hospital, Toronto, Ontario; Frederic Morin, Centre de Recherche Musculo-Squelettique, Trois-Rivieres, Quebec; Wojcieh Olszynski, Saskatoon Osteoporosis Centre, Saskatoon, Saskatchewan; Jean-Pascal Ouellet, Q&T Recherche Inc., Sherbrooke, Quebec; Terri L. Paul, St. Joseph’s Healthcare, London, Ontario; Eric St. Amour, Q&T Recherche Outaouais Inc., Hull, Quebec; Michelle Tolszcuk, Q&T Recherche Inc., Sherbrooke, Quebec; Chui Kin Yuen, Manitoba Clinic Medical Corporation, Winnipeg, Manitoba. Chile: Jose Adolfo Rodriguez, Universidad Catolica de Chile, Santiago. Croatia: Mirko Korsic, University Hospital Center, Zagreb; Petar Lozo, Outpatient Clinic Lozo Zad, Zadar; Dalibor Krpan, General Hospital Sveti Duh, Zagreb; Zvonko Kusic, Sestre Milosrdnice Zagreb, Zagreb; Nikola Ljubojevic, University Hospital Centre Zagreb, Zagreb; Franjo Skreb, Avenija Gojka, Zagreb. Denmark: Peter Alexandersen, Center for Clinical and Basic Research, Veijle; Yu Bagger, Center for Clinical and Basic Research, Ballerup; Hans Christian Hoeck, Center for Clinical and Basic Research, Aalborg; Hans-Jorgen Lehman, Center for Clinical and Basic Research, Veijle; Lusine Movseyan, Center for Clinical and Basic Research, Ballerup; Laszio Tanko, Center for Clinical and Basic Research, Aalborg. Estonia: Katre Maasalu, Orthopaedic Outpatient & Clinical Research Center, Tartu; Ivo Valter, Center for Clinical & Basic Research, Tallinn. Finland: Jorma Heikkinen, ODL Terveys OY Osteoporosis Clinic, Oulu; Martti Kormano, Meliläinen Turku, Turku; Heikki Kroger, Kuopio University Hospital, Kuopio; Lasse Makinen, Meliläinen Turku, Turku; Anna-Maija Rossi, LIKES Research Center, Jyvaskyla; Harri Selanne, LIKES Research Center, Jyvaskyla; Marjo Tuppurainen, Kuopio University Hospital, Kuopio. France: Caude-Laurent Benhamou, Hopital Porte Madeleine, Orleans; Pierre Delmas, Hopital E Herriot, Lyon; Marie-Christine DeVernejoul, Hopital Lariboisiere, Paris. Germany: Manfred Hartard, Klinikum der Universitat Munchen, Munchen; Wolfgang Spieler, Rheumat; Praxis Spieler, Zerbst. Greece: Constantine Phenekos, Red Cross Hospital, Athens. Hungary: Tibor Balazs, Rethy Pal Hospital, Bekescaba; Janos Gal, County Hospital Bacs-Kiskum, Kecskemet; Katalin Tarjan, Diosszilagyi S. Hospital, Mako. Italy: Fiorenzo de Cicco Nardone, Instituto di Clinica Ostetrica e Ginecologia, Roma; Paolo Falaschi, Università degli Studi La Sapienza; Carlos Gennari, Instituto di Clinica Medica, Siena; Ranuccio Nuti, Istituto di Clinica medica, Siena. Lithuania: Vidmantas Alekna, National Osteoporisis Centre, Vilnius; Asta Baranauskaite, Kaunas Medical University Hospital, Kaunas. Mexico: Melchor Alpizar, Instituto Mexicano de Investigacion Clinica, Mexico City; Oscar Roberto Antunez, Instituto Mexicano de Investigacion Clinica, Mexico City; Gerardo Guzman, Instituto Mexicano de Investigacion Clinica, Mexico City; Alfonzo Murillo, Instituto Mexicano de Investigacion Clinica, Mexico City; Maria Fernanda Rio de la Loza, Institucion Cineo-Obstetrica y de Perinatologia, Mexico City; Javier Santos, Instituto Mexicano de Investigacion Clinica, Mexico City. New Zealand: Anna Fenton, The Oxford Clinic, Christchurch; Patrick John Manning, Endocrinology & Nephrology Research Unit, Dunedin; Gagrath Pradeep Singh, North Shore Hospital, Auckland. The Netherlands: G. L. Bremer, Justus Medische Expertises, Eindhoven; J. M. Bruggraaff, Scheper Hospital Emmen, Emmen; J. C. Jonker, Justus Medische Expertises, Eindhoven; Paul Lips, Dienst Endocrinologie, Amsterdam; Dyonne van Duren, Menox BV, Nijmegan; Tj. D. Ypma, Scheper Hospital Emmen, Emmen. Norway: Johan Halse, Osteoporoseklinikken Specialistsenteret Pilesredet Park, Olso; Hans Olav Hoivik, Hedmark Medisinske Senter AS, Hamar; Erik Snorre Ofjord, Center for Clinical Trials, Bergen; Arne Skag, Hedmark Medisinske Senter AS, Hamar; Unni Syversen, St. Olavs HF University Hospital, Trondheim. Poland: Piotr Gluszko, Malopolskie Centrum Medyczne, Krakow; Jerzy Przedlacki, Krajowe Centrum Osteoporozy, Warszawa; Thomasz Rechberger, University School of Medicine Hospital, Lublin; Andrzej Sawicki, Centrum Medycne Osteomed, Warszawa; Anna Sidorowicz-Bialynicka, Skandynawskie Centrum Medyczne, Wroclaw; Krysztof Sodowski, Centrum Medyczne, Katowice. Romania: Catalin Codreanu, Centrului Metodologic de Reumatologie Dr. I. Stoia, Bucuresti; Ileana Duncea, Spitalul Clinic Judetean Cluj, Cluj-Napoca; Aurelian Ranetti, Spitalul Clinic de Urgenta Militar Central Dr. Carol Davila, Bucuresti; Eusebie Zbranca, Spitalul Clinic Judetean de Urgenta “Sf. Spiridon,” Iasi. Russia: Lioudmila Alexeeva, Federal State Agency Polyclinic #1, Moscow; Lidia Benevolenskaya, Rheumatology Institute of Russian Academy of Medical Sciences, Moscow; Ivan Dedof, National Research Center for Endocrinology, Moscow; Sergey Mazurenko, Central Outpatients Clinic Medical and Sanitary Unit #122, Saint Petersburg; Rafael Oganov, State Scientific Research Centre for Preventive Medicine, Moscow; Vladimir Potin, Scientific Research Institute of Obstetrics and Gynecology, Saint Petersburg; Svetlana Rodinova, N. N. Priorov Central Scientific Research Institute of Traumatology and Orthopedics, Moscow; Liudmila Rozhinskaya, National Research Center for Endocrinology, Moscow; Vladimir Simonenko, Central Military Hospital, Moscow; Eugeny Zotkin, Munitsipal Clinical Hospital #25, Saint Petersburg. Slovakia: Rastislav Dzurik, Slovenska Zdravotnicka Univ., Bratislava; Zdenko Killinger, Internal Clinic, Bratislava; Pavol Masaryk, Institute of Rheumatic Diseases, Piestany. South Africa: Susan Brown, Donald Gordon Medical Centre, Johannesburg; Charles Davis, The Willows, Pretoria; Graham Ellis, Somerset West Mediclinic, Somerset West; Stan Lipschitz, The Osteoporosis Clinic, Johannesburg; Tobie de Villers, Panorama Mediclinic, Parow; Albert de Weerd, Pretoria East Private Hospital, Pretoria. Spain: Armando Laffon, Hospital De La Princesa, Madrid; Emilio Martin-Mola, Hospital La Paz, P de la Castellana; Santiago Palacios, Instituto Palacios, Madrid. United States: Nader Abdelsayed, Centennial Hills Ob-Gyn Associates, North Las Vegas, NV; John Abernethy, Gainesville, FL; Rowell Ashford, Research Solutions, Birmingham, AL; Jeffrey B. Baker, Rosemark Women’s Care Specialists, Idaho Falls, ID; Mira Baron, Rapid Medical Research Inc., Cleveland, OH; Clyde Bench, IHC Clinical Research Foundation, Salt Lake City, UT; Bruce Berwald, Radiant Research—St. Louis, St. Louis, MO; Eugene Boling, Boling Clinical Trials, Upland, CA; Michael Bolognese, Bethesda Health Research, Bethesda, MD; Phillip Bressman, Tennessee Women’s Care PC, Nashville, TN; Elizabeth Bretton, Albuquerque Clinical Trials Inc., Albuquerque, NM; David Browning, Healthcare Research Consultants, Sarasota, FL; Charles Chesnut, UWMC Osteoporosis Research Group, Seattle, WA; Clancy Cone, Northwest Physicians Research Network, Missoula, MT; Lydia Corn, Visions Clinical Research—Sarasota, Sarasota, FL; Mary Cronin, Medical College of Wisconsin, Milwaukee, WI; Kurt G. Datz, Bismarck Health Center, Bismarck, ND; Steven K. Elliott, Medisphere Medical Research Center LLC, Evansville, IN; Ronald Emkey, Radiant Research—Reading, Wyomissing, PA; Joseph Fanciullo, Avera Research Institute, Sioux Falls, SD; H. Frank Farmer, Radiant Research—Daytona, Daytona Beach, FL; Ruth Freeman, Albert Einstein College of Medicine, Bronx, NY; Francis Gallagher, Radiant Research—Reading, Wyomissing, PA; Harry Geisberg, Radiant Research—Anderson, Anderson, SC; Catherine Gerrish, Odyssey Research, Watertown, SD; Gita Gidwani, Rapid Medical Research Inc., Cleveland, OH; Charles Goldsmith, Clinical Research Institute of South Florida, Aventura, FL; Maria Greenwald, Desert Medical Advances, Palm Desert, CA; Louis Gringeri, Clinical Research Division, Newtown, PA; Robert Harlin, Coastal Clinical Research Inc., Mobile, AL; Lonnie Clayton Harrell, Metrolina Medical Research, Charlotte, NC; Richard Hedrick, Salem Research Group, Winston-Salem, NC; Mark L. Henderson, Acadia Clinical Research LLC, Bangor, ME; Joseph G. Herrmann, Radiant Research—St. Louis, St. Louis, MO; Vernon Hershberger, Daystar Clinical Research, Akron, OH; Marvin Heuer, Gainesville, FL; Reid Holkesvik, Avera United Clinic, Aberdeen, SC; Mary K. Holm, Odyssey Research Services, Fargo, ND; Joseph Hume, University of Kansas Medical Center, Kansas City, KS; Rajeev Jain, Advanced Healthcare, Milwaukee, WI; Shelly Kafka, Altoona Center for Clinical Research, Duncansville, PA; William Kaye, Metabolic Research Institute Inc., West Palm Beach, FL; Michael Keller, OsNet San Diego Arthritis and Osteoporosis Medical Clinic, San Diego, CA; Howard Kenney, Arthritis Northwest, Spokane, WA; Joseph Kerlin, American Health Network, Avon, IN; Ellen Kim, Albuquerque Clinical Trials Inc., Albuquerque, NM; Howard Knapp, Deaconness Billings Clinical Research Division, Billings, MT; Rebecca Knight, Balanced Health Research Center, Peoria, IL; Michael Kohen, Coastal Medical Research, Port Orange, FL; Norman Koval, The Center For Rheumatology and Bone Research, Wheaton, MD; Stephen Kupersmith, Elite Medical Research Inc., Sellersville, PA; Rogert Lang, Hamden, CT; John Lawson, The Center for Rheumatology and Bone Research, Washington, DC; Samuel Lederman, Radiant Research—West Palm Beach, West Palm Beach, FL; Mitchell Lowenstein, The Arthritis Center, Palm Harbor, FL; Barry Lubin, Hampton Roads Center for Clinical Research, Norfolk, VA; Norman Lunde, Twin Cities Clinical Research, Brooklyn Center, MN; Daniel Lynch, Americas Doctors—Winchester Research Group, Libertyville, IL; Daryl MacCarter, Americas Doctors—Idaho Arthritis & Osteoporosis, Meridian, ID; Richard Martin, Arthritis Education and Treatment Center PLLC, Grand Rapids, MI; Thomas Melchione, Sacramento Women’s Health Research, Sacramento, CA; Joseph Millen Jr, Visions Clinical Research—Sarasota, Sarasota, FL; Bruce A. Miller, Radiant Research—Scottsdale, Scottsdale, AZ; Sam Miller, S.A.M. Clinical Research Center, San Antonio, TX; Richard Mills, Coastal Carolina Research Center, Mt. Pleasant, SC; Valerie Montgomery-Rice, University of Kansas Medical Center, Kansas City, KS; David Morris, Healthcare Research Consultants, Sarasota, FL; Rup K. Nagala, Southeast Medical Center, Oakes, ND; Michael Noss, Radiant Research—Cincinnati, Cincinnati, OH; Meenakshi Patel, Valley Medical Center Primary Care, Centerville, OH; Tushar Patel, Fall River Walk-In Emergency Medical Office, Fall River, MA; Brian Peck, Arthritis Center of CT, Waterbury, CT; Alfred Poindexter III, Advances in Health Inc., Houston, TX; Steven Portes, Americas Doctors—Winchester Research Group, Libertyville, IL; H. Malin Prupas, Arthritis Center of Reno, Reno, NV; Patricia Reiff, Radiant Research, Phoenix, AZ; James F. Rich, Research Center for Clinical Medicine, Camp Hill, PA; Marilyn Richardson, University of Kansas Medical Center, Kansas City, KS; Dennis Riff, Advanced Clinical Research Institute, Anaheim, CA; Syed Wajih Rizvi, Odyssey Research Services, Fargo, ND; John Robbins, University of California at Davis, Sacramento, CA; Clifford Rosen, St. Joseph Hospital, Bangor, ME; Robert Rosenberg, The Center for Rheumatology and Bone Research, Wheaton, MD; Julio Rosenstock, Dallas Diabetes and Endocrine Center, Dallas, TX; Kenneth Saag, University of Alabama-Birmingham, Birmingham, AL; Suzanne Satterfield, UT Department of Preventive Medicine, Memphis, TN; Allan Sawyer, Hope Research Institute, Phoenix, AZ; Phillipe Saxe, Delray Research Associates, Delray Beach, FL; Donald Schumacher, The Center for Nutrition and Preventive Medicine, Charlotte, NC; Craig Scoville, Rosemark Women’s Care Specialists, Idaho Falls, ID; Mohamed Sebai, Boling Clinical Trials, Upland CA; Jeffrey Seiler, Radiant Research—West Palm Beach, West Palm Beach, FL; William Shergy, Rheumatology Associates of North Alabama, Huntsville, AL; Sherwyn Schwartz, Diabetes & Glandular Disease Research Associates PA, San Antonio, TX; Joshua R. Shua-Haim, Alzheimer’s Research Corp./Meridian Institute for Aging, Manchester Township, NJ; Lee Shulman, University of Illinois at Chicago, Chicago, IL; Suthin Songcharoen, Arthritis and Osteoporosis Treatment and Research Center, Flowood, MS; Thomas Stavoy, Atlantic Institute of Clinical Research, Daytona Beach, FL; Patricia Stephenson, Elite Medical Research Inc., Sellersville, PA; Cynthia Strout, Coastal Carolina Research Center, Mt. Pleasant, SC; Stephen Swanson, Women’s Clinical of Lincoln PC, Lincoln, NE; G. Michael Swor, Visions Clinical Research—Sarasota, Sarasota, FL; James Taborn, Midwest Arthritis Center, Kalamazoo, MI; Jerome Targovik, Radiant Research—Scottsdale, Scottsdale, AZ; John Tesser, Radiant Research, Phoenix, AZ; Joseph Torchia, Research Center for Clinical Medicine, Camp Hill, PA; Suzanne Trupin, Women’s Health Practice, Champaign, IL; Wulf Utian, Rapid Medical Research Inc., Cleveland, OH; Arthur Virshup, Arthritis and Rheumatology Associates of Palm Beach, West Palm Beach, FL; Eric Wedell, IMG Clinical Research, Cheyenne, WY; Johnathan Weshsler, Centennial Hills Ob-Gyn Associates, North Las Vegas, NV; Richard White, University of California at Davis, Sacramento, CA; Robert Wilson, Associates in Research, Fresno, CA; J. Michael Wise, Bozeman Urgent Care, Bozeman, MT; Ray Wolff, Radiant Research—St. Louis, St. Louis, MO; Grattan Woodson, OsNet Atlanta Research Center, Decatur, GA; Mary C. Yankaskas, Clinical Physiology Associates, Fort Meyers, FL; Edward Zbella, DMI Health Care Group Inc., Largo, FL.

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Silverman, S.L., Chines, A.A., Kendler, D.L. et al. Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporos Int 23, 351–363 (2012). https://doi.org/10.1007/s00198-011-1691-1

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