Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis

BMC Musculoskeletal Disorders

Volumn 11, Issue , 2010, Pages

  Christiansen, Claus ^a   Chesnut, Charles H ^b   Adachi, Jonathan D ^c   Brown, Jacques P ^d   Fernandes, César E ^e   Kung, Annie W C ^f   Palacios, Santiago ^g   Levine, Amy B ^h   Chines, Arkadi A ^h   Constantine, Ginger D ^h  

^a CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^b UNIVERSITY OF WASHINGTON   (United States)

^c MCMASTER UNIVERSITY   (Canada)

^d LAVAL UNIVERSITY   (Canada)

^e FACULDADE DE MEDICINA DO ABC   (Brazil)

^f UNIVERSITY OF HONG KONG   (Hong Kong)

^g Instituto Palacios de Salud Y Medicina de la Mujer   (Spain)

^h PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BAZEDOXIFENE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; RALOXIFENE; TRIACYLGLYCEROL; BONE DENSITY CONSERVATION AGENT; INDOLE DERIVATIVE; SELECTIVE ESTROGEN RECEPTOR MODULATOR;

ABDOMINAL PAIN; ACCIDENTAL INJURY; ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; BREAST CARCINOMA; BREAST CYST; BREAST EXAMINATION; BREAST TUMOR; CENTRAL RETINA VEIN THROMBOSIS; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYSTIC FIBROSIS; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENDOMETRIUM CARCINOMA; ENDOMETRIUM HYPERPLASIA; FEMALE; FIBROCYSTIC BREAST DISEASE; FLU LIKE SYNDROME; GYNECOLOGICAL EXAMINATION; HEADACHE; HEART DISEASE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HOT FLUSH; HUMAN; HYPERTENSION; INCIDENCE; LEG CRAMP; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MASTALGIA; MULTICENTER STUDY; OVARY CARCINOMA; OVARY CYST; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STROKE; SUPERFICIAL THROMBOPHLEBITIS; TRANSIENT ISCHEMIC ATTACK; URINARY TRACT INFECTION; UTERUS BLEEDING; VAGINA BLEEDING; VENOUS THROMBOEMBOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; BONE DENSITY CONSERVATION AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INDOLES; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PLACEBOS; RALOXIFENE; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TREATMENT OUTCOME;

EID: 77954885674     PISSN: None     EISSN: 14712474     Source Type: Journal    
DOI: 10.1186/1471-2474-11-130     Document Type: Article

References (20)

1. Epidemiology of osteoporotic fractures. E Dennison C Cooper, Horm Res 2000 54 58 63 11146381
2. Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society. North American Menopause Society, Menopause 2006 13 340 367 10.1097/01.gme.0000222475.93345.b3 16735931
3. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. C MacLean S Newberry M Maglione M McMahon V Ranganath M Suttorp W Mojica M Timmer A Alexander M McNamara,, et al. Ann Intern Med 2008 148 197 213 18087050
4. Developing a SERM: stringent preclinical selection criteria leading to an acceptable candidate (WAY-140424) for clinical evaluation. BS Komm CR Lyttle, Ann N Y Acad Sci 2001 949 317 326 10.1111/j.1749-6632.2001.tb04039.x 11795370
5. Bazedoxifene acetate: a selective estrogen receptor modulator with improved selectivity. BS Komm YP Kharode PV Bodine HA Harris CP Miller CR Lyttle, Endocrinology 2005 146 3999 4008 10.1210/en.2005-0030 15961563
6. Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women. S Ronkin R Northington E Baracat MG Nunes DF Archer G Constantine JH Pickar, Obstet Gynecol 2005 105 1397 1404 15932835 (Pubitemid 40734275)
7. Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. PD Miller AA Chines C Christiansen HC Hoeck DL Kendler EM Lewiecki G Woodson AB Levine G Constantine PD Delmas, J Bone Miner Res 2008 23 525 535 10.1359/jbmr.071206 18072873
8. Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis. JV Pinkerton DF Archer WH Utian JC Menegoci AB Levine AA Chines GD Constantine, Menopause 2009 16 1102 1108 10.1097/gme.0b013e3181a816be 19546825
9. 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. SL Silverman C Christiansen HK Genant S Vukicevic JR Zanchetta TJ de Villiers GD Constantine AA Chines, J Bone Miner Res 2008 23 1923 1934 10.1359/jbmr.080710 18665787
10. Bazedoxifene, a selective estrogen receptor modulator: effects on the endometrium, ovaries, and breast from a randomized controlled trial in osteoporotic postmenopausal women. DF Archer JV Pinkerton WH Utian JC Menegoci TJ de Villiers CK Yuen AB Levine AA Chines GD Constantine, Menopause 2009 16 1109 1115 10.1097/gme.0b013e3181a818db 19543129
11. The search for the ideal SERM. B Arun M Anthony B Dunn, Expert Opin Pharmacother 2002 3 681 691 10.1517/14656566.3.6.681 12036407
12. Adverse events reported by postmenopausal women in controlled trials with raloxifene. GC Davies WJ Huster Y Lu L Plouffe Jr M Lakshmanan, Obstet Gynecol 1999 93 558 565 10.1016/S0029-7844(98)00476-1 10214833
13. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. B Ettinger DM Black BH Mitlak RK Knickerbocker T Nickelsen HK Genant C Christiansen PD Delmas JR Zanchetta J Stakkestad,, et al. JAMA 1999 282 637 645 10.1001/jama.282.7.637 10517716
14. Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation. D Grady B Ettinger E Moscarelli L Plouffe Jr S Sarkar A Ciaccia S Cummings for the Multiple Outcomes of Raloxifene Evaluation Investigators, Obstet Gynecol 2004 104 837 844 15458908
15. 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
16. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. E Barrett-Connor L Mosca P Collins MJ Geiger D Grady M Kornitzer MA McNabb NK Wenger, N Engl J Med 2006 355 125 137 10.1056/NEJMoa062462 16837676 (Pubitemid 44050394)
17. Novo Nordisk drops levormeloxifene. SCRIP 1998 2374 18
18. Smith Kline Beecham drops idoxifene for osteoporosis. SCRIP 1999 2431 21
19. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. SR Cummings S Eckert KA Krueger D Grady TJ Powles JA Cauley L Norton T Nickelsen NH Bjarnason M Morrow,, et al. JAMA 1999 281 2189 2197 10.1001/jama.281.23.2189 10376571
20. 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. VG Vogel JP Costantino DL Wickerham WM Cronin RS Cecchini JN Atkins TB Bevers L Fehrenbacher ER Pajon Jr JL Wade III,, et al. JAMA 2006 295 2727 2741 10.1001/jama.295.23.joc60074 16754727