Denosumab (Prolia) and osteonecrosis of the jaw
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Posted on 6/26/2023 by Greg Kammeyer |
A systematic analysis of events reported in clinical trials Ana Boquete-Castro 1, Gerardo Gómez-Moreno 2, José Luis Calvo-Guirado 3, Antonio Aguilar-Salvatierra 4, Rafael Arcesio Delgado-Ruiz 5 8963 patients with a variety of solid tumors reported in seven randomized controlled trials (RCTs) were included in the systematic analysis. The overall incidence of ONJ in patients with cancer receiving denosumab was 1.7% [95% CI: 0.9-3.1%]. The use of denosumab was associated with a significantly increased risk of ONJ in comparison with bisphosphonates (BPs)/placebo treatment (RR 1.61, 95% CI: 1.05-2.48, P = 0.029). Similar results were observed for prostate cancer (RR 3.358, 95% CI: 1.573-7.166, P = 0.002). Conclusions: Denosumab combined with risk factors such as dental extraction, poor oral hygiene, use of removable apparatus, and chemotherapy may favor the development of ONJ. |