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A pooled analysis of fall incidence from placebo-controlled trials of denosumab

Journal of Bone and Mineral Research Feb 09, 2020

Chotiyarnwong P, McCloskey E, Eastell R, et al. - Considering the pivotal placebo-controlled fracture trial of the RANKL inhibitor denosumab in women with postmenopausal osteoporosis, that demonstrated association of treatment with a lower incidence of non-fracture-related falls, researchers conducted this ad hoc exploratory analysis pooling data from five placebo-controlled trials of denosumab to ascertain consistency across trials, if any, of the reduction of fall incidence. They performed inclusion of trials in women with postmenopausal osteoporosis and low bone mass, men with osteoporosis, women taking adjuvant aromatase inhibitors for breast cancer, and men taking androgen deprivation therapy for prostate cancer. In the analysis, 10,036 individuals were included; 5,030 received denosumab 60 mg subcutaneously once every 6 months for 12–36 months and 5,006 received placebo. As per Kaplan–Meier estimates, occurrence of falls in the placebo group was reported in 6.5% vs 5.2% in the denosumab group. This suggests the possibility of reduction in the risk of falls in correlation to receiving denosumab in addition to its established fracture risk reduction by reducing bone resorption and increasing bone mass.
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