Investigation of the Influencing Factors on the Incidence of Vertebral Fracture:: A Meta-analysis Based on Placebo Data of Randomized Clinical Trials

Therapeutic Innovation & Regulatory Science
Tsuyoshi KobayashiMamoru Narukawa

Abstract

The incidence of vertebral fracture is commonly used as a primary endpoint in randomized clinical trials of pharmaceutical agents for osteoporosis. In order to investigate the impact of ethnic/regional difference in osteoporosis clinical trials on the incidence of vertebral fracture, we examined the correlation between the incidence of vertebral fracture in the placebo group and baseline bone mineral density (BMD), ethnic and regional differences, or other factors by meta-regression analysis. We studied a total of 21 trials involving 28,425 patients treated with placebo, which were identified through MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials. A univariate meta-regression showed a significant correlation between the proportion of subjects experiencing new vertebral fracture and the proportion of Caucasian subjects (coefficient = 0.223, P = .045), and the proportion of subjects with prevalent vertebral fracture (0.161, P < .001). Baseline lumbar spine BMD did not show significant correlations. As a result of multivariate meta-regression analysis with the factors with P < .2 by the univariate meta-regression, the proportion of subjects with prevalent vertebral fracture was identified as an influencing fac...Continue Reading

References

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