Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled phase 3 trial

Osteoporosis International

Volumn 22, Issue 2, 2011, Pages 567-576

  De Villiers, T J ^g   Chines, A A ^a   Palacios, S ^b   Lips, P ^c   Sawicki, A Z ^d   Levine, A B ^a   Codreanu, C ^e   Kelepouris, N ^a   Brown, J P ^f  

^a PFIZER INC   (United States)

^b Palacios Institute of Women's Health   (Spain)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d Warsawian Center of Osteoporosis and Calcium Metabolism   (Poland)

^e Center for Rheumatic Diseases   (Romania)

^f LAVAL UNIVERSITY   (Canada)

^g NONE

Author keywords

Bazedoxifene; Osteoporosis; Postmenopausal; Safety; SERMs; Tolerability

Indexed keywords

BAZEDOXIFENE; CALCIUM; PLACEBO; RALOXIFENE; VITAMIN D;

ABDOMINAL PAIN; ACCIDENTAL INJURY; AGE DISTRIBUTION; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; BREAST; BREAST CANCER; BREAST CARCINOMA; BREAST CYST; BRONCHITIS; CATARACT; CONSTIPATION; COUGHING; DEEP VEIN THROMBOSIS; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENDOMETRIAL NEOPLASIA; ENDOMETRIUM; ENDOMETRIUM CARCINOMA; ENDOMETRIUM HYPERPLASIA; FACTUAL DATABASE; FEMALE; FIBROCYSTIC BREAST DISEASE; FLU LIKE SYNDROME; HEADACHE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HOT FLUSH; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; INFECTION; INSOMNIA; LEG CRAMP; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MASTALGIA; OSTEOARTHRITIS; OVARY CARCINOMA; OVARY CYST; PAIN; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINA VEIN THROMBOSIS; STROKE; TRANSIENT ISCHEMIC ATTACK; URINARY TRACT INFECTION; UTERUS BLEEDING; VAGINA BLEEDING; VENOUS THROMBOEMBOLISM;

AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HOT FLASHES; HUMANS; INDOLES; MIDDLE AGED; MUSCLE CRAMP; OSTEOPOROSIS, POSTMENOPAUSAL; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 78651506084     PISSN: 0937941X     EISSN: 14332965     Source Type: Journal    
DOI: 10.1007/s00198-010-1302-6     Document Type: Article

References (31)

1. North American Menopause Society 2006 Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society Menopause 13 340 367 10.1097/01.gme.0000222475.93345.b3
2. A Fontana PD Delmas 2003 Selective estrogen receptors modulators in the prevention and treatment of postmenopausal osteoporosis Endocrinol Metab Clin N Am 32 219 232 1:CAS:528:DC%2BD3sXjtFOjsbk%3D 10.1016/S0889-8529(02)00057-9
3. E Dennison C Cooper 2000 Epidemiology of osteoporotic fractures Horm Res 54 58 63 1:CAS:528:DC%2BD3MXhs12rsrs%3D 11146381
4. OS Atik I Gunal F Korkusuz 2006 Burden of osteoporosis Clin Orthop Relat Res 443 19 24 16462421 10.1097/01.blo.0000200248.34876.fe
5. A Caliri L De Filippis GL Bagnato GF Bagnato 2007 Osteoporotic fractures: mortality and quality of life Panminerva Med 49 21 27 1:STN:280: DC%2BD2s3lvFaluw%3D%3D 17468730
6. C MacLean S Newberry M Maglione M McMahon V Ranganath M Suttorp W Mojica M Timmer A Alexander M McNamara SB Desai A Zhou S Chen J Carter C Tringale D Valentine B Johnsen J Grossman 2008 Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis Ann Intern Med 148 197 213 18087050
7. EM Lewiecki 2009 Emerging drugs for postmenopausal osteoporosis Expert Opin Emerg Drugs 14 129 144 1:CAS:528:DC%2BD1MXivFSmurw%3D 19249985 10.1517/14728210902766813
8. B Arun M Anthony B Dunn 2002 The search for the ideal SERM Expert Opin Pharmacother 3 681 691 1:CAS:528:DC%2BD38Xlt1Cqsr8%3D 12036407 10.1517/14656566.3.6.681
9. HS Taylor 2009 Designing the ideal selective estrogen receptor modulator-an achievable goal? Menopause 16 609 615 19182697 10.1097/gme. 0b013e3181906fa3
10. A Cranney JD Adachi 2005 Benefit-risk assessment of raloxifene in postmenopausal osteoporosis Drug Saf 28 721 730 1:CAS:528:DC%2BD2MXhtVWjsLnI 16048357 10.2165/00002018-200528080-00006
11. SR Goldstein N Nanavati 2002 Adverse events that are associated with the selective estrogen receptor modulator levormeloxifene in an aborted phase III osteoporosis treatment study Am J Obstet Gynecol 187 521 527 1:CAS:528:DC%2BD38XotFGqtLo%3D 12237621 10.1067/mob.2002.123938
12. W Shelly MW Draper V Krishnan M Wong RB Jaffe 2008 Selective estrogen receptor modulators: an update on recent clinical findings Obstet Gynecol Surv 63 163 181 18279543
13. E Barrett-Connor L Mosca P Collins MJ Geiger D Grady M Kornitzer MA McNabb NK Wenger 2006 Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women N Engl J Med 355 125 137 1:CAS:528: DC%2BD28Xmsl2ktrs%3D 16837676 10.1056/NEJMoa062462
14. D Grady B Ettinger E Moscarelli L Plouffe Jr S Sarkar A Ciaccia S Cummings 2004 Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation Obstet Gynecol 104 837 844 1:CAS:528:DC%2BD2cXptFKjt7c%3D 15458908 10.1097/01.AOG.0000137349.79204.b8
15. S Martino JA Cauley E Barrett-Connor TJ Powles J Mershon D Disch RJ Secrest SR Cummings 2004 Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene J Natl Cancer Inst 96 1751 1761 1:CAS:528:DC%2BD2cXhtVCrsrjM 15572757 10.1093/jnci/djh319
16. PD Miller AA Chines C Christiansen HC Hoeck DL Kendler EM Lewiecki G Woodson AB Levine G Constantine PD Delmas 2008 Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study J Bone Miner Res 23 525 535 1:CAS:528:DC%2BD1cXltFyhsb8%3D 18072873 10.1359/jbmr.071206
17. JV Pinkerton DF Archer WH Utian JC Menegoci AB Levine AA Chines GD Constantine 2009 Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis Menopause 16 1102 1108 19546825 10.1097/gme.0b013e3181a816be
18. SL Silverman C Christiansen HK Genant S Vukicevic JR Zanchetta TJ de Villiers GD Constantine AA Chines 2008 Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial J Bone Miner Res 23 1923 1934 1:CAS:528:DC%2BD1MXosVylsbo%3D 18665787 10.1359/jbmr.080710
19. DF Archer JV Pinkerton WH Utian JC Menegoci TJ de Villiers CK Yuen AB Levine AA Chines GD Constantine 2009 Bazedoxifene, a selective estrogen receptor modulator: effects on the endometrium, ovaries, and breast from a randomized controlled trial in osteoporotic postmenopausal women Menopause 16 1109 1115 19543129 10.1097/gme.0b013e3181a818db
20. Silverman S, Chines A, Zanchetta JR, Genant H, Kendler D, Rio de la Loza F, Kung A, Constantine GD, Adachi J (2009) Sustained efficacy of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. J Bone Miner Res 24 (Suppl 1). Available at: http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx? aid=2643ea2f-c4ab-4eb6-9798-09050bb21b6b. Accessed 10 Dec 2009
21. GC Davies WJ Huster Y Lu L Plouffe Jr M Lakshmanan 1999 Adverse events reported by postmenopausal women in controlled trials with raloxifene Obstet Gynecol 93 558 565 1:CAS:528:DyaK1MXit1Ohur4%3D 10214833 10.1016/S0029-7844(98) 00476-1
22. Pfizer Inc (2008) FABLYN® (lasofoxifene tartrate) 0.5 mg tablets. NDA 22-242. Reproductive Health Drugs Advisory Committee Briefing Document, 08 September 2008. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4381b1-02- Pfizer.pdf. Accessed 10 Dec 2009
23. AC Fleischer JE Wheeler IT Yeh B Kravitz C Jensen B MacDonald 1999 Sonographic assessment of the endometrium in osteopenic postmenopausal women treated with idoxifene J Ultrasound Med 18 503 512 1:STN:280: DyaK1MzisFKnsw%3D%3D 10400054
24. P Alexandersen BJ Riis JA Stakkestad PD Delmas C Christiansen 2001 Efficacy of levormeloxifene in the prevention of postmenopausal bone loss and on the lipid profile compared to low dose hormone replacement therapy J Clin Endocrinol Metab 86 755 760 1:CAS:528:DC%2BD3MXht1KntLw%3D 11158042 10.1210/jc.86.2.755
25. SmithKline Beecham 1999 SmithKline Beecham drops idoxifene for osteoporosis SCRIP 2431 21
26. Novo Nordisk 1998 Novo Nordisk drops levormeloxifene SCRIP 2374 18
27. S Ronkin R Northington E Baracat MG Nunes DF Archer G Constantine JH Pickar 2005 Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women Obstet Gynecol 105 1397 1404 1:CAS:528:DC%2BD2MXls1eitb4%3D 15932835 10.1097/01.AOG.0000163253.27610.b9
28. B Fisher JP Costantino DL Wickerham CK Redmond M Kavanah WM Cronin V Vogel A Robidoux N Dimitrov J Atkins M Daly S Wieand E Tan-Chiu L Ford N Wolmark 1998 Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 study J Natl Cancer Inst 90 1371 1388 1:CAS:528:DyaK1cXmtlelurs%3D 9747868 10.1093/jnci/90.18.1371
29. B Ettinger DM Black BH Mitlak RK Knickerbocker T Nickelsen HK Genant C Christiansen PD Delmas JR Zanchetta J Stakkestad CC Gluer K Krueger FJ Cohen S Eckert KE Ensrud LV Avioli P Lips SR Cummings for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators 1999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial JAMA 282 637 645 1:CAS:528: DyaK1MXlvVKqurg%3D 10517716 10.1001/jama.282.7.637
30. SR Cummings S Eckert KA Krueger D Grady TJ Powles JA Cauley L Norton T Nickelsen NH Bjarnason M Morrow ME Lippman D Black JE Glusman A Costa VC Jordan 1999 The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation JAMA 281 2189 2197 1:CAS:528:DyaK1MXktFGitL0%3D 10376571 10.1001/jama.281.23.2189
31. VG Vogel JP Costantino DL Wickerham WM Cronin RS Cecchini JN Atkins TB Bevers L Fehrenbacher ER Pajon Jr JL Wade III A Robidoux RG Margolese J James SM Lippman CD Runowicz PA Ganz SE Reis W Caskill-Stevens LG Ford VC Jordan N Wolmark 2006 Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial JAMA 295 2727 2741 1:CAS:528: DC%2BD28XmtFOltLc%3D 16754727 10.1001/jama.295.23.joc60074