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| |  No Significant Relationship Between FRAX Score and Efficacy of Alendronate for Nonvertebral, Clinical Fractures: Presented at ASBMR By John Otrompke DENVER -- September 14, 2009 -- A clinical tool used to estimate the future risk of fractures did not have an association with any reduction in risk due to the use of alendronate, according to a study presented here at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR). Furthermore, the overall nonvertebral fracture risk reduction for alendronate did not reach statistical significance. “FRAX [Fracture Risk Assessment] predicted major osteoporotic fractures in the study,” said Steven Cummings, MD, University of California at San Francisco, California, during an oral presentation on September 12. While the effect of alendronate did not reach statistical significance, “the reduction in risk was greater in those with low bone mineral density for major osteoporotic fractures,” he said. FRAX is a standardised measure which estimates the 10-year probability of major osteoporotic fracture in the spine, hip, wrist and humerus from 9 clinical risk factors, with or without measuring femoral neck bone mineral density (BMD). Prior analyses found that clodronate and bazedoxifene reduced nonvertebral and clinical fracture more effectively in women with higher FRAX probabilities. “We wondered [if we could] replicate the result in the Fracture Intervention Trial [FIT] with alendronate,” said Dr. Cummings. The study looked at 4,432 postmenopausal women randomised to placebo or alendronate for 4 years. Researchers used data from FIT to test whether alendronate was more effective in women with high FRAX score. Risk factors in FRAX were assessed at baseline and FRAX probabilities were calculated by the World Health Organization. Median age for those in the study was 68 years. Of those in the placebo arm, 35% had a prior history of fracture, compared with 36% of those women who received alendronate. FRAX, which was recently updated for use in the United States, predicted future fracture in these women, but did not correlate with any efficiency of alendronate. The effect of alendronate was greater in women with lower BMD at the femoral neck, however. Results were similar for major osteoporotic fractures whether or not FRAX calculations included femoral neck BMD. The analysis presented at the meeting was not supported by any company, but funding for the FIT study was provided by Amgen, Inc; Eli Lilly and Company; and Pfizer Inc. [Presentation title: Efficacy of Alendronate for Reducing Nonvertebral and Clinical Fractures by FRAX Score Categories. Abstract 1030]
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