Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled study

Osteoporosis International, 08/01/2011

Silverman SL et al. – The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.

Methods

  • 4,216 postmenopausal women with osteoporosis enrolled
  • 2-year extension of 3-year, randomized, double-blind, placebo-controlled, phase 3 trial
  • In core study (N=7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo
  • Raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years
  • 5-year findings reported for bazedoxifene 20 and 40/20 mg and placebo
  • Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in BMD and bone turnover markers

Results

  • At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P<0.05), with relative risk reductions of 35% and 40%
  • Non-vertebral fracture incidence was similar among groups
  • In a subgroup of higher-risk women (n=1,324; femoral neck T-score ≤-3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P=0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P<0.05)
  • Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P<0.05) and was generally safe and well tolerated

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