The relationship between osteoporotic fracture risk and a surrogate: Apparent discrepancies between analyses based on individual patient data and summary statistics
Article first published online: 13 SEP 2004
Copyright © 2004 John Wiley & Sons, Ltd.
Volume 3, Issue 3, pages 205–212, July/September 2004
How to Cite
Barton, I. (2004), The relationship between osteoporotic fracture risk and a surrogate: Apparent discrepancies between analyses based on individual patient data and summary statistics. Pharmaceut. Statist., 3: 205–212. doi: 10.1002/pst.123
- Issue published online: 14 SEP 2004
- Article first published online: 13 SEP 2004
- regression analysis;
- clinical trial
There is debate within the osteoporosis research community about the relationship between the risk of osteoporotic fracture and the surrogate measures of fracture risk. Meta-regression analyses based on summary data have shown a linear relationship between fracture risk and surrogate measures, whereas analyses based on individual patient data (IPD) have shown a nonlinear relationship. We investigated the association between changes in a surrogate measure of fracture incidence, in this case a bone turnover marker for resorption assessed in the three risedronate phase III clinical programmes, and incident osteoporosis-related fracture risk using regression models based on patient-level and trial-level information. The relationship between osteoporosis-related fracture risk and changes in bone resorption was different when analysed on the basis of IPD than when analysed on the basis of a meta-analytic approach (i.e., meta-regression) using summary data (e.g., treatment effect based on treatment group estimates). This inconsistency in our findings was consistent with those in the published literature. Meta-regression based on summary statistics at the trial level is not expected to reflect causal relationships between a clinical outcome and surrogate measures. Analyses based on IPD make possible a more comprehensive analysis since all relevant data on a patient level are available. Copyright © 2004 John Wiley & Sons Ltd.