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Odanacatib for the treatment of postmenopausal osteoporosis: Results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study

The Lancet Diabetes & Endocrinology Nov 27, 2019

McClung MR, O'Donoghue ML, Papapoulos SE, et al. - Researchers conducted the Long-term Odanacatib Fracture Trial (LOFT), a multicentre, randomized, double-blind, placebo-controlled, event-driven study, at 388 outpatient clinics in 40 countries in order to determine the effectiveness and safety of odanacatib to decrease fracture risk in postmenopausal women with osteoporosis. In this trial, they randomly assigned 16,071 women (aged at least 65 years) to treatment: 8,043 to odanacatib and 8028 to placebo; these women were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between −2·5 and −4·0 if no previous radiographic vertebral fracture, or between −1·5 and −4·0 with a previous vertebral fracture. Outcomes indicate that odanacatib administration decreases the risk of fracture, but, was associated with an enhanced risk of cardiovascular events, specifically stroke, in postmenopausal women with osteoporosis. On balancing the benefit and risk, further development of odanacatib for the treatment of osteoporosis has been abandoned by the study's sponsor.
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