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Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis
Date:3/23/2009

ral neck and total hip BMD, serum bone turnover markers, mammographic breast density and safety.(1) The study included postmenopausal women with osteoporosis with a mean age of 63 years and a mean lumbar spine BMD T-score of -2.9.

12-month results included:(1)

  • Arzoxifene significantly increased BMD at all sites to a greater extent than raloxifene, respectively (p<0.05 for all comparisons):
    • Lumbar spine BMD (2.8 percent vs. 1.7 percent)
    • Femoral neck BMD (1.5 percent vs. 0.5 percent)
    • Total hip BMD (1.5 percent vs. 0.8 percent)
    • For lumbar spine and femoral neck, this effect was statistically significant as early as six months.
  • Arzoxifene significantly suppressed bone turnover to a greater extent than raloxifene, respectively (p<0.05 for all comparisons):
    • CTX (biochemical marker of bone resorption); -40.6 percent vs. -29.8 percent
    • PINP (biochemical marker of bone formation) : -41.5 percent vs. -30.8 percent
    • Arzoxifene suppressed bone turnover to a greater extent than raloxifene as early as three months.
  • New or worsening hot flushes were reported less frequently with arzoxifene versus raloxifene (7.0 percent vs. 16.7 percent; p=0.009).
  • There were not any between-group or within-group differences in change of percentage of breast density.
  • The proportion of women reporting one or more adverse events, including vaginal bleeding, did not differ between treatment groups.
  • No cases of endometrial polyps, hyperplasia or cancer were reported.
  • Nasopharyngitis and bronchitis were reported more frequently with arzoxifene versus raloxifene (10.1 percent vs. 2.5 percent, and 5.1 percent vs. 0 percent, respectively; p less than or equal to 0.
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SOURCE Eli Lilly and Company
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