Objective  To systematically review the efficacy and safety of denosemab and zoledronic acid in patients with solid tumors bone metastases and multiple myeloma.

Methods  Pubmed, Embase, Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched for randomized controlled trials (RCTs) related to denosemab and zoledronic acid in the solid tumors bone metastases and multiple myeloma from inception to November 21, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, and Meta-analysis was performed by using RevMan 5.3 software.

Results  A total of 5 RCTs, involving 8 957 patients were included. The results of Meta-analysis showed that denosumab was effective in delaying the time to first bone-related event (SRE) (HR=0.85, 95%CI 0.80 to 0.92, P<0.001) and the time to first and subsequent SRE time (HR=0.87, 95%CI 0.79 to 0.96, P=0.004) were superior to zoledronic acid. Denosumab had lower incidence of nephrotoxicity (RR=0.70, 95%CI 0.58 to 0.85, P<0.001), acute phase response (RR=0.46, 95%CI 0.40 to 0.51, P<0.001), anemia (RR=0.91, 95%CI 0.85 to 0.98, P=0.008) and appetite decreased/anorexia (RR=0.89, 95%CI 0.81 to 0.98, P=0.02), but the incidence of hypocalcemia was higher (RR=1.72, 95%CI 1.49 to 1.99, P<0.001). There were no significant differences between denosumab and zoledronic acid in terms of overall survival, time to disease progression, incidence of adverse events and serious adverse events (P>0.05).

Conclusion  Current evidence shows that compared with zoledronic acid, denosemab can significantly delay SREs induced by solid tumors bone metastases and multiple myeloma. In terms of safety, the risk of denosemab-induced nephrotoxicity, acute phase reactions, anemia and decreased appetite/anorexia are lower, but the risk of denosemab-induced hypocalcemia is higher.

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