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N Engl J Med. 2010 Feb 25;362(8):686-96. doi: 10.1056/NEJMoa0808692.

Lasofoxifene in postmenopausal women with osteoporosis.

Collaborators (138)

Cummings SR, Delmas P, Eastell R, Ensrud K, LaCroix A, Reid D, Sriram U, Vukicevic S, Zanchetta J, Powles T, Allred C, Goss P, Osborne K, Colgan T, Goldstein SR, Neven P, Runowicz CD, Cohen L, Sechtem U, Welty F, Johnson SR, Russell G, Cosman F, Barter P, Laird NM, Gardiol AA, Zanchetta J, Messina OD, Seeman E, Nicholson G, Hooper M, Graham JJ, Eden J, Stuckey BG, Geusens P, Boonen S, De Melo NR, Zerbini CA, Yuen CK, Brown J, Ste-Marie LG, Adachi J, Hanley DA, Josse RG, Kendler D, Olszynski WP, Castro R, Krpan D, Giljevic Z, Skreb F, Hyldstrup L, Langdahl BL, Rashed A, Maasalu K, Tammemae L, Piirisild KL, Heikkinen J, Kormano M, Valimaki MJ, Roux CC, Delmas PD, Hartard M, Doren M, Lau E, Balogh A, Horvath K, Tulassay Z, Kanakatte PM, Srinivasan B, Mehrotra RN, Patni R, Menon PS, Thomas M, Seshadri MS, Ammini AC, O'Brien M, Brandi ML, Adami S, Itabashi A, Okamoto S, Fujita N, Sawamoto A, Omata R, Han IK, Alekna V, Kazanavicius G, Jurgutis R, Balderas I, Santos J, Correa-Rotter R, Halse JI, Hoye K, Ofjord ES, Sawicki A, Marcinowska-Suchowierska E, Czerwinski E, Zosin I, Zbranca E, Codreanu C, Gzgzyan AM, Benevolenskaya LI, Dedov II, Oganov R, Smetnik V, Jordaan PJ, De Villiers TJ, Lipschitz S, Ellis G, Calaf J, Hawkins F, Mellstrom D, Kucukdeveci A, Kirazli Y, Keen R, Reid DM, Savani N, Moffett AH Jr, Silverfield JC, Bolognese MA, McKenney JM, Rosenstock J, Greenwald MW, Lewiecki M, Miller SS, Lederman SN, Chesnut CH 3rd, Gallagher JC, Hangartner TN, Johnson KC, Ensrud K, Cauley JA, LaCroix A, Lewis CE, Broy SB, Sherman L, Barrett-Connor EL, Wallace RB, Orwoll ES.

Author information

  • 1San Francisco Coordinating Center, California Pacific Medical Center Research Institute, and University of California, San Francisco, San Francisco, USA. scummings@sfcc-cpmc.net

Erratum in

  • N Engl J Med. 2011 Jan 20;364(3):290. Kucu kdeveci A [corrected to Kucukdeveci, A].

Abstract

BACKGROUND:

The effects of lasofoxifene on the risk of fractures, breast cancer, and cardiovascular disease are uncertain.

METHODS:

In this randomized trial, we assigned 8556 women who were between the ages of 59 and 80 years and had a bone mineral density T score of -2.5 or less at the femoral neck or spine to receive once-daily lasofoxifene (at a dose of either 0.25 mg or 0.5 mg) or placebo for 5 years. Primary end points were vertebral fractures, estrogen receptor (ER)-positive breast cancer, and nonvertebral fractures; secondary end points included major coronary heart disease events and stroke.

RESULTS:

Lasofoxifene at a dose of 0.5 mg per day, as compared with placebo, was associated with reduced risks of vertebral fracture (13.1 cases vs. 22.4 cases per 1000 person-years; hazard ratio, 0.58; 95% confidence interval [CI], 0.47 to 0.70), nonvertebral fracture (18.7 vs. 24.5 cases per 1000 person-years; hazard ratio, 0.76; 95% CI, 0.64 to 0.91), ER-positive breast cancer (0.3 vs. 1.7 cases per 1000 person-years; hazard ratio, 0.19; 95% CI, 0.07 to 0.56), coronary heart disease events (5.1 vs. 7.5 cases per 1000 person-years; hazard ratio, 0.68; 95% CI, 0.50 to 0.93), and stroke (2.5 vs. 3.9 cases per 1000 person-years; hazard ratio, 0.64; 95% CI, 0.41 to 0.99). Lasofoxifene at a dose of 0.25 mg per day, as compared with placebo, was associated with reduced risks of vertebral fracture (16.0 vs. 22.4 cases per 1000 person-years; hazard ratio, 0.69; 95% CI, 0.57 to 0.83) and stroke (2.4 vs. 3.9 cases per 1000 person-years; hazard ratio, 0.61; 95% CI, 0.39 to 0.96) Both the lower and higher doses, as compared with placebo, were associated with an increase in venous thromboembolic events (3.8 and 2.9 cases vs. 1.4 cases per 1000 person-years; hazard ratios, 2.67 [95% CI, 1.55 to 4.58] and 2.06 [95% CI, 1.17 to 3.60], respectively). Endometrial cancer occurred in three women in the placebo group, two women in the lower-dose lasofoxifene group, and two women in the higher-dose lasofoxifene group. Rates of death per 1000 person-years were 5.1 in the placebo group, 7.0 in the lower-dose lasofoxifene group, and 5.7 in the higher-dose lasofoxifene group.

CONCLUSIONS:

In postmenopausal women with osteoporosis, lasofoxifene at a dose of 0.5 mg per day was associated with reduced risks of nonvertebral and vertebral fractures, ER-positive breast cancer, coronary heart disease, and stroke but an increased risk of venous thromboembolic events. (ClinicalTrials.gov number, NCT00141323.)

2010 Massachusetts Medical Society

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PMID:
20181970
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