Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis

  • Pinkerton J
  • Archer D
  • Utian W
 et al. 
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Abstract

Objective: The aim of this study was to examine the endometrial, ovarian, and breast safety of bazedoxifene, a novel selective estrogen-receptor modulator, in postmenopausal women at risk for osteoporosis. Methods: Healthy postmenopausal women (N = 1,583; mean age, 57.6 y) with lumbar spine or femoral neck bone mineral density T scores between -1 and -2.5 and/or other clinical risk factors for osteoporosis were enrolled in a 24-month, phase 3, randomized, double-blind, placebo- and active-controlled trial. They received daily treatment with bazedoxifene 10, 20, or 40 mg; placebo; or raloxifene 60 mg. Reproductive safety assessments included periodic transvaginal ultrasound measurements of endometrial thickness, ovarian volume, and presence of ovarian cysts; periodic endometrial biopsies; and adverse event reporting. Results: Bazedoxifene was not associated with a significant change from baseline in mean endometrial thickness at month 24. The percentage of participants with a change from baseline in endometrial thickness or endometrial thickness greater than 5 mm at month 24 was similar among groups. There was no consensus diagnosis of endometrial hyperplasia or malignancy in the bazedoxifene or raloxifene groups; the rates of other histologic findings, including endometrial polyps, were low (

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Authors

  • JoAnn V Pinkerton

  • David F Archer

  • Wulf H Utian

  • Jose C Menegoci

  • Amy B Levine

  • Arkadi A Chines

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