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Is Bazedoxifene Safe For Postmenopausal Women?

Evaluating long-term efficacy for osteoporosis

Postmenopausal women with osteoporosis can find long-term benefit from bazedoxifene, which was found to be safe and effective over 7 years in a double-blind, osteoporosis treatment study of 7,492 generally healthy participants. The 2-year extension of the original 3-year core study, which found 20 mg and 40 mg dosages reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis, further determined:

• At 7 years, cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%).

• Bazedoxifene had no effect on overall incidence of nonvertebral fractures.

• Mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%.

• Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events and serious adverse events.

Citation: Palacios S, Silverman S, de Villiers TJ, et al. A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture. Menopause. 2015;22(8):806-813. doi: 10.1097/GME.0000000000000419.