Bazedoxifene acetate: a novel selective estrogen receptor modulator for the prevention and treatment of postmenopausal osteoporosis.

ABSTRACT

Postmenopausal osteoporosis is an increasing worldwide health concern affecting an estimated 200 million individuals. Despite a wide range of available treatment options, many patients are not being treated or discontinue therapy. The ongoing need for new osteoporosis therapies has led to the development of new selective estrogen receptor modulators (SERMs) with an ideal tissue selectivity profile and beneficial effects on bone without undesirable effects on the endometrium and breast. Bazedoxifene acetate, a novel SERM in clinical development for the prevention and treatment of postmenopausal osteoporosis, resembles this ideal profile more closely than other currently available SERMs. Results from large prospective phase III trials showed that it increases bone mineral density, reduces bone turnover rate and decreases the risk for new vertebral fractures. Moreover, based on a post hoc analysis of a subgroup of women with a higher risk for fracture, bazedoxifene was demonstrated to significantly reduce the incidence of nonvertebral fractures compared with both raloxifene hydrochloride and placebo. Furthermore, it was reported to be well tolerated, with a favorable safety profile and no evidence of endometrial or breast tissue stimulation. Bazedoxifene represents an important new treatment option for women at risk for osteoporosis and fracture.