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Newly Published Phase III Study Shows Arzoxifene Significantly Increased Bone Mineral Density
Date:4/8/2009

ults from that trial are anticipated in late 2009.

About the "FOUNDATION" study

Effects of Arzoxifene on Bone Mineral Density and Endometrium in Postmenopausal Women with Normal or Low Bone Mass

In this Phase III, double-blind, two-year, multi-center trial, 331 postmenopausal women with normal or low bone mass were randomized to receive arzoxifene 20 mg/day or placebo. All subjects received elemental calcium 500 mg/day. The study's primary endpoints were change in lumbar spine and total hip BMD, and endometrial safety measured by endometrial histology.

The study included women who were at least two years postmenopausal and between the ages of 45 and 60 with an intact uterus. Subjects' femoral neck or lumbar spine T-scores were between 0 and -2.5, and they did not have pre-existing spine fractures.

24-month results included:(1)

  • Arzoxifene significantly increased the lumbar spine BMD by 2.9% vs placebo (arzoxifene, 1.6%; placebo, -1.3%, p<0.001); and total hip BMD by 2.2% vs placebo (arzoxifene 1.1%; placebo, -1.1%, p<1.001).
  • Arzoxifene significantly decreased biochemical marker of bone resorption C-terminal cross-linking telopeptide of type I collagen (CTX, arzoxifene -30.01 percent, placebo 3.79 percent; p<0.001); and biochemical marker of bone formation serum N-terminal propeptide of type I collagen (PINP, arzoxifene -38.81 percent, placebo -10.27 percent; p<0.001).
  • There was no significant difference overall in the number of subjects reporting adverse events in the arzoxifene group compared with the placebo group, with the exception of vaginal yeast infection (arzoxifene 4%, placebo 0%, p=0.02).
  • New or worsening hot flushes were not significantly different between the arzoxifene and placebo groups (arzoxifene 12%, placebo 11%, p=0.87).
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SOURCE Eli Lilly and Company
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