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Activity Number:
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154
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308999 |
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Title:
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Statistical Evaluation of Bone Mineral Density as a Surrogate Endpoint for Fracture with or Without Baseline Consideration
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Author(s):
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Peiqi Chen*+ and Asad Rana
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Companies:
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Eli Lilly and Company and Eli Lilly and Company
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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Bone mineral density ; surrogate endpoint ; fracture risk
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Abstract:
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The statistical methodologies to validate bone mineral density (BMD) change as a surrogate for fracture risk reduction are still in debate. The objective of this paper was to determine whether BMD change or the endpoint BMD value is the more appropriate covariate for fracture risk. Using data from a large osteoporosis trial, we examined (1) the relationship between BMD change and fracture risk; (2) the relationship of baseline BMD and BMD change with fracture risk; and (3) the relationship between the endpoint BMD value and fracture risk. The unintuitive relationship observed was that a high fracture risk was associated with a large increase in BMD when we ignored the baseline value. We further found that both the baseline BMD value and BMD change were important determinants of fracture risk. Therefore, it is more appropriate to use the endpoint BMD value in statistical modeling.
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