Arzoxifene versus raloxifene: Effect on bone and safety parameters in postmenopausal women with osteoporosis

Osteoporosis International

Volumn 23, Issue 3, 2012, Pages 1091-1101

  Kendler, D L ^a   Palacios, S ^b   Cox, D A ^c   Stock, J ^c   Alam, J ^c   Dowsett, S A ^c   Zanchetta, J ^d  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

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

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSIDAD DEL SALVADOR   (Argentina)

Author keywords

Arzoxifene; Bone mineral density (BMD); Bone turnover marker; Safety; SERM

Indexed keywords

ANTITHROMBIN III; ARZOXIFENE; CALCIUM; CARBOXY TERMINAL TELOPEPTIDE; PROTEIN C; PROTEIN S; RALOXIFENE; VITAMIN D;

ADULT; ARTICLE; BONE DENSITY; BONE TURNOVER; BREAST CANCER; BRONCHITIS; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SAFETY; ENDOMETRIUM HYPERPLASIA; FEMALE; HOT FLUSH; HUMAN; LUMBAR SPINE; MULTICENTER STUDY; MUSCLE SPASM; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; UTERUS CANCER;

ABSORPTIOMETRY, PHOTON; AGED; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; BONE REMODELING; DOUBLE-BLIND METHOD; FEMALE; FEMUR NECK; HIP JOINT; HOT FLASHES; HUMANS; LUMBAR VERTEBRAE; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PIPERIDINES; RALOXIFENE; THIOPHENES; TREATMENT OUTCOME;

EID: 84857441133     PISSN: 0937941X     EISSN: 14332965     Source Type: Journal    
DOI: 10.1007/s00198-011-1587-0     Document Type: Article

References (28)

1. AD Palkowitz AL Glasebrook KJ Thrasher KL Hauser LL Short DL Phillips BS Muehl M Sato PK Shetler GJ Cullinan TR Pell HU Bryant 1997 Discovery and synthesis of [6-hydroxy-3-[4-[2-(1-piperidinyl)ethoxy]phenoxy]-2-(4- hydroxyphenyl)]benzothiophene: a novel, highly potent, selective estrogen receptor modulator J Med Chem 40 1407 1416 9154963 10.1021/jm970167b 1:CAS:528:DyaK2sXis1agsbY%3D (Pubitemid 27200757)
2. M Sato CH Turner T Wang MD Adrian E Rowley HU Bryant 1998 LY353381.HCl: a novel raloxifene analog with improved SERM potency and efficacy in vivo J Pharmacol Exp Ther 287 1 7 9765314 1:CAS:528:DyaK1cXmvVSqt7k%3D (Pubitemid 29140178)
3. N Suh AL Glasebrook AD Palkowitz HU Bryant LL Burris JJ Starling HL Pearce C Williams C Peer Y Wang MB Sporn 2001 Arzoxifene, a new selective estrogen receptor modulator for chemoprevention of experimental breast cancer Cancer Res 61 8412 8415 11731420 1:CAS:528:DC%2BD3MXptFCktLY%3D (Pubitemid 33131117)
4. N Suh WW Lamph AL Glasebrook TA Grese AD Palkowitz CR Williams R Risingsong MR Farris RA Heyman MB Sporn 2002 Prevention and treatment of experimental breast cancer with the combination of a new selective estrogen receptor modulator, arzoxifene, and a new rexinoid, LG 100268 Clin Cancer Res 8 3270 3275 12374698 1:CAS:528:DC%2BD38XosFKht7s%3D (Pubitemid 35155040)
5. PD Delmas HK Genant GG Crans JL Stock M Wong E Siris JD Adachi 2003 Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial Bone 33 522 532 14555255 10.1016/S8756-3282(03)00241-2 1:STN:280:DC%2BD3svnslSgsw%3D%3D (Pubitemid 37222378)
6. B Ettinger DM Black BH Mitlak RK Knickerbocker T Nickelsen HK Genant C Christiansen PD Delmas JR Zanchetta J Stakkestad CC Glüer K Krueger FJ Cohen S Eckert KE Ensrud LV Avioli P Lips SR Cummings 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 10517716 10.1001/jama.282.7.637 1:CAS:528:DyaK1MXlvVKqurg%3D (Pubitemid 29384151)
7. R Downs A Moffett C DA Ghosh K Harper 2008 Effects of arzoxifene on bone turnover and safety in postmenopausal women with low bone mass: results from a 6-month phase 2 study J Bone Miner Res 23 S470
8. M Bolognese JH Krege WH Utian R Feldman S Broy DL Meats J Alam M Lakshmanan M Omizo 2009 Effects of arzoxifene on bone mineral density and endometrium in postmenopausal women with normal or low bone mass J Clin Endocrinol Metab 94 2284 2289 19351734 10.1210/jc.2008-2143 1:CAS:528: DC%2BD1MXosl2lurk%3D
9. SR Cummings M McClung JY Reginster D Cox B Mitlak J Stock M Amewou-Atisso T Powles P Miller J Zanchetta C Christiansen 2011 Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women J Bone Miner Res 26 397 404 20658564 10.1002/jbmr.191 1:CAS:528:DC%2BC3MXjt1Wqs78%3D
10. JW Byng NF Boyd E Fishell RA Jong MJ Yaffe 1994 The quantitative analysis of mammographic densities Phys Med Biol 39 1629 1638 15551535 10.1088/0031-9155/39/10/008 1:STN:280:DC%2BD2crnsFahuw%3D%3D (Pubitemid 24306719)
11. DM Black SR Cummings DB Karpf JA Cauley DE Thompson MC Nevitt DC Bauer HK Genant WL Haskell R Marcus SM Ott JC Torner SA Quandt TF Reiss KE Ensrud 1996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group Lancet 348 1535 1541 8950879 10.1016/S0140-6736(96)07088-2 1:CAS:528: DyaK2sXisFCktQ%3D%3D (Pubitemid 26411651)
12. HA Pols D Felsenberg DA Hanley J Stepán M Muñoz-Torres TJ Wilkin G Qin-sheng AM Galich K Vandormael AJ Yates B Stych 1999 Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group Osteoporos Int 9 461 468 10550467 10.1007/PL00004171 1:CAS:528:DyaK1MXkt1CktrY%3D (Pubitemid 29231740)
13. ST Harris NB Watts HK Genant CD McKeever T Hangartner M Keller CH Chesnut 3rd J Brown EF Eriksen MS Hoseyni DW Axelrod PD Miller 1999 Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group JAMA 282 1344 1352 10527181 10.1001/jama.282.14.1344 1:CAS:528:DyaK1MXmvFansr0%3D (Pubitemid 29483192)
14. DM Black PD Delmas R Eastell IR Reid S Boonen JA Cauley F Cosman P Lakatos PC Leung Z Man C Mautalen P Mesenbrink H Hu J Caminis K Tong T Rosario-Jansen J Krasnow TF Hue D Sellmeyer EF Eriksen SR Cummings 2007 HORIZON pivotal fracture trial once-yearly zoledronic acid for treatment of postmenopausal osteoporosis N Engl J Med 356 1809 1822 17476007 10.1056/NEJMoa067312 1:CAS:528:DC%2BD2sXltVSktLc%3D (Pubitemid 46698462)
15. SR Cummings K Ensrud PD Delmas AZ LaCroix S Vukicevic DM Reid S Goldstein U Sriram A Lee J Thompson RA Armstrong DD Thompson T Powles J Zanchetta D Kendler P Neven R Eastell PEARL Study Investigators 2010 Lasofoxifene in postmenopausal women with osteoporosis N Engl J Med 362 686 696 20181970 10.1056/NEJMoa0808692 1:CAS:528:DC%2BC3cXisFOqsro%3D
16. SR Cummings J San Martin MR McClung ES Siris R Eastell IR Reid P Delmas HB Zoog M Austin A Wang S Kutilek S Adami J Zanchetta C Libanati S Siddhanti C Christiansen FREEDOM Trial 2009 Denosumab for prevention of fractures in postmenopausal women with osteoporosis N Engl J Med 361 756 765 19671655 10.1056/NEJMoa0809493 1:CAS:528:DC%2BD1MXhtVWls7nF
17. A Cano WM van Baal 2001 The mechanisms of thrombotic risk induced by hormone replacement therapy Maturitas 40 17 38 11684370 10.1016/S0378-5122(01) 00270-5 1:CAS:528:DC%2BD3MXnvFGqt7s%3D (Pubitemid 33048840)
18. F Cosman M Baz-Hecht M Cushman MD Vardy JD Cruz JW Nieves M Zion R Lindsay 2005 Short-term effects of estrogen, tamoxifen and raloxifene on hemostasis: a randomized-controlled study and review of the literature Thromb Res 116 1 13 15850603 10.1016/j.thromres.2004.09.014 1:CAS:528: DC%2BD2MXjsVGltbk%3D (Pubitemid 40546320)
19. GD Azevedo RF Franco MS Baggio TM Maranhao RA Ferriani MF Silva de Sa 2003 Effects of raloxifene therapy on the anticoagulant system in postmenopausal women Climacteric 6 140 145 12841884 1:CAS:528:DC%2BD3sXlvFelsrg%3D (Pubitemid 36714086)
20. AL Eilertsen L Sandvik MC Mowinckel TO Andersen E Qvigstad PM Sandset 2007 Differential effects of conventional and low dose oral hormone therapy (HT), tibolone, and raloxifene on coagulation and fibrinolysis Thromb Res 120 371 379 17156824 10.1016/j.thromres.2006.10.013 1:CAS:528:DC%2BD2sXmtlait7g%3D (Pubitemid 46879904)
21. M Sgarabotto M Baldini A Dei Cas C Manotti A Luciana Barilla M Rinaldi L Benassi A Bacchi Modena 2007 Effects of raloxifene and continuous combined hormone therapy on haemostasis variables: a multicenter, randomized, double-blind study Thromb Res 119 85 91 16499954 10.1016/j.thromres.2006.01.001 1:CAS:528:DC%2BD28Xht1CgsL3L (Pubitemid 44716210)
22. B Ettinger DM Black BH Mitlak RK Knickerbocker T Nickelsen HK Genant C Christiansen PD Delmas JR Zanchetta J Stakkestad CC Glüer K Krueger FJ Cohen S Eckert KE Ensrud LV Avioli P Lips 1999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators JAMA 282 637 645 10517716 10.1001/jama.282.7.637 1:CAS:528:DyaK1MXlvVKqurg%3D Erratum in: JAMA 1999 Dec 8;282:2124 (Pubitemid 29384151)
23. B Fisher JP Constantino DL Wickerham, et al. 1998 Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project PI Study J Natl Cancer Inst 90 1371 1388 9747868 10.1093/jnci/90.18.1371 1:CAS:528:DyaK1cXmtlelurs%3D (Pubitemid 28439961)
24. 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 12 1923 1934 18665787 10.1359/jbmr.080710 1:CAS:528: DC%2BD1MXosVylsbo%3D
25. R Eastell I Barton RA Hannon A Chines P Garnero PD Delmas 2003 Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate J Bone Miner Res 18 1051 1056 12817758 10.1359/jbmr.2003.18.6.1051 1:CAS:528:DC%2BD3sXkslOhsb0%3D (Pubitemid 37294942)
26. MC Hochberg S Greenspan RD Wasnich P Miller DE Thompson PD Ross 2002 Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents J Clin Endocrinol Metab 87 1586 1592 11932287 10.1210/jc.87.4.1586 1:CAS:528:DC%2BD38XivFKlt7k%3D (Pubitemid 34615244)
27. E Seeman 2007 Is a change in bone mineral density a sensitive and specific surrogate of anti-fracture efficacy? Bone 41 308 317 17644058 10.1016/j.bone.2007.06.010 1:STN:280:DC%2BD2svntlaqtw%3D%3D (Pubitemid 47199158)
28. P Szulc PD Delmas 2008 Biochemical markers of bone turnover: potential use in the investigation and management of postmenopausal osteoporosis Osteoporos Int 19 1683 1704 18629570 10.1007/s00198-008-0660-9 1:CAS:528:DC%2BD1cXht12kur7P