Risk of falls in patients with low bone mineral density : Analysis of placebo arms from clinical trials.

BACKGROUND

Falls are a major risk factor for osteoporotic fractures. Therefore, the aim of this study was to analyze the risk of falls in patients with low bone mineral density (BMD) and osteoporosis.

METHODS

The risk of falls in patients with low BMD and/or osteoporosis was analyzed using data from placebo arms of clinical trials, indexed on clinicaltrials.gov. The risk was estimated using a single arm meta-analysis method and by applying a binary random effects model. In addition, meta-regression analyses were performed to identify associations between risk of falls and age, body mass index (BMI) and BMD.

RESULTS

A total of 8762 patients from placebo arms of clinical trials were included into the analysis. Risk of falls was 5.2% (0.052, 95% confidence interval [95% CI] 0.022-0.082; n = 8714; I = 97.3%, p ≤ 0.001) in patients with low BMD and/or osteoporosis and 5.9% (0.059, 95% CI 0.036-0.083; n = 7819; I = 87.8%, p ≤ 0.001) in patients with osteoporosis. A significant association with risk of falls was identified for age in patients with low BMD and/or osteoporosis. BMD at total hip (TH; coefficient -0.077, 95% CI: -0.113--0.040, p ≤ 0.001; n = 7715) and femoral neck (FN; coefficient -0.044, 95% CI -0.065--0.023, p ≤ 0.001; n = 7662) were significantly associated with risk of falls in patients with osteoporosis.

CONCLUSION

This analysis identified the risk of falls in patients with low BMD and osteoporosis and an association of falls with age and BMD. Therefore, patients with osteoporosis need to receive mandatory fall risk mitigation measures, and the BMD at total hip or femoral neck could function as an indicator for the risk of falling.