Journal Article

Lasofoxifene in Postmenopausal Women with Osteoporosis

Delmas, Pierre D, Thompson, John, Eastell, Richard, Zanchetta, Jose, Goldstein, Steven, Powles, Trevor, Kendler, David, Reid, David M, Vukicevic, Slobodan, Neven, Patrick, Ensrud, Kristine, Armstrong, Roisin A, Lee, Andy, Cummings, Steven R, LaCroix, Andrea Z, Sriram, Usha, Thompson, David D

2010

Overview

Women between 59 and 80 years of age with a bone mineral density T score of –2.5 or less at the femoral neck or spine received the selective estrogen-receptor modulator lasofoxifene (either 0.25 or 0.5 mg daily) or placebo for 5 years. Lasofoxifene was associated with lower risks of fractures, estrogen-receptor–positive breast cancer, coronary heart disease, and stroke, with no increase in endometrial cancer, but there was an increase in venous thromboembolic events. In women with osteoporosis, lasofoxifene was associated with lower risks of fractures, estrogen-receptor–positive breast cancer, coronary heart disease, and stroke, with no increase in endometrial cancer, but there was an increase in venous thromboembolic events. Lasofoxifene is a nonsteroidal selective estrogen-receptor modulator that decreases bone resorption, bone loss, and low-density- lipoprotein (LDL) cholesterol in postmenopausal women. 1 We conducted the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) trial to determine whether lasofoxifene would reduce the risk of fractures, estrogen receptor (ER)–positive breast cancer, and cardiovascular disease among postmenopausal women with osteoporosis. Methods Study Design The PEARL trial was an international, randomized, placebo-controlled trial. Subjects received 1 g of calcium and 400 to 800 IU of vitamin D and placebo during a 6- to 8-week run-in period; women who received 75% or more of these pills were . . .

• Publisher: Massachusetts Medical Society
• Subject: Aged / Biological and medical sciences / Bone density / Bone Density - drug effects / Bone Density Conservation Agents - adverse effects / Bone Density Conservation Agents - therapeutic use / Bones / Breast Neoplasms - epidemiology / Breast Neoplasms - prevention & control / Cancer / Coronary Disease - epidemiology / Coronary Disease - prevention & control / Diseases of the osteoarticular system / Female / Fractures, Bone - epidemiology / Fractures, Bone - prevention & control / General aspects / Humans / Medical sciences / Middle Aged / Osteoporosis / Osteoporosis, Postmenopausal - complications / Osteoporosis, Postmenopausal - drug therapy / Osteoporosis. Osteomalacia. Paget disease / Pyrrolidines - adverse effects / Pyrrolidines - therapeutic use / Receptors, Estrogen - analysis / Risk / Selective Estrogen Receptor Modulators - adverse effects / Selective Estrogen Receptor Modulators - therapeutic use / Spinal Fractures - epidemiology / Spinal Fractures - prevention & control / Stroke - epidemiology / Stroke - prevention & control / Tetrahydronaphthalenes - adverse effects / Tetrahydronaphthalenes - therapeutic use / Venous Thromboembolism - chemically induced / Venous Thromboembolism - epidemiology