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Denosumab, cancer treatment and risk of osteonecrosis of the jaw


Qi et al. carried out a meta-analysis of data from randomized controlled trials published between 1966 and 2012 to elucidate the link between denosumab treatment in cancer patients and the risk and incidence of osteonecrosis of the jaw (ONJ).

Seven randomized controlled trials were included, which had a total of 8963 participants. Patients with solid tumors of various types who were treated with denosumab showed an overall incidence of ONJ of 1.7% (95% CI: 0.9–3.1%). Patients who received denosumab were at significantly greater risk of ONJ compared to those treated with bisphosphonates or given a placebo (relative risk 1.61, 95% CI: 1.05–2.48, P=0.029).

An analysis done only in prostate cancer patients showed a similar pattern, with a greater risk of ONJ in those treated with denosumab vs placebo or bisphosphonates (relative risk 3.358, 95% CI: 1.573–7.166, P=0.002). Taken together, patients with cancers other than prostate cancer showed a trend towards increased risk of ONJ when given denosumab treatment, but this was not significant (relative risk 1.142, 95% CI: 0.678–1.921, P=0.618).

Editor’s comment: This meta-analysis of seven cancer trials with denosumab confirms an increased risk of ONJ with denosumab at the doses used in cancer treatment and further suggests a greater risk compared to bisphosphonates, albeit a non-significant one.

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