Lasofoxifene, a Next Generation Selective Estrogen Receptor Modulator (SERM), in the Prevention of Bone Loss in Postmenopausal Women
Mark Ettinger*1, Elliott Schwartz2, Ron Emkey3, Alfred H Moffett4, Michael Bolognese5, Stuart R Weiss6, Andrew Lee7. 1Stuart, FL; 2Fdn for Osteoporosis Res and Treatment, Oakland, CA; 3Reading, PA; 4OB-Gyn Assoc of Mid Florida, FL; 5the Bethesda Hlth Res Ctr, Bethesda, MD; 6Radiant Res, San Diego, CA; 7Pfizer Inc, New London, CT.
Lasofoxifene is a potent next generation SERM under development for prevention and treatment of postmenopausal osteoporosis. Results of 1yr, Phase 2, randomized, doubleblind, placebo-controlled study examining efficacy in bone loss prevention and safety of lasofoxifene are reported.
All lasofoxifene doses increased in lumbar spine BMD statistically significantly compared with pbo (P<0.001); there was no significant difference between groups for hip BMD. All lasofoxifene doses decreased biochemical markers of bone turnover (P<0.01) and LDL-cholesterol (P<0.001) statistically significantly compared with pbo. Similar to spine BMD, this effect was 2/3 of effect with PremPro. Overall safety of lasofoxifene was comparable to pbo. Incidence rates for uterine/ovarian change were low with lasofoxifene. Most commonly reported AEs associated with lasofoxifene were hot flushes, leg cramps, and leukorrhea and with PremPro included breakthrough bleeding and breast pain.