BoneKEy Reports | BoneKEy Watch
The rate of osteonecrosis of the jaw in patients with bone metastases
DOI:10.1038/bonekey.2012.23
Patients with metastatic bone disease treated with bisphosphonates are at risk of osteonecrosis of the jaw (ONJ), but the level of risk has not been determined accurately. Combined analysis of three large randomized trials of denosumab vs zoledronic acid in patients with advanced cancer reveals that the true incidence of ONJ in this setting is 1–2% per year.
This conclusion was made after using proper adjudication criteria to analyze the rate of ONJ in 5723 patients with bone metastases secondary to solid tumors or myeloma treated with either 120 mg denosumab or 4 mg zoledronic acid every four weeks. Signs of ONJ were detected by oral examinations conducted at baseline and every six months. Study durations ranged from 34 to 41 months; median time on study for zoledronic acid treated patients was 12.1 months, and 12.6 months for the denosumab group.
1.3% of patients who received zoledronic acid and 1.8% of those who received denosumab developed ONJ; this difference was not significant. Over 60% of the ONJ cases required tooth extraction but only conservative treatment was required in >95%, resulting in ONJ resolution in about a third of those affected.
Editor's comment: The rate of ONJ was similar between the two treatments, so is not specifically related to bisphosphonates and their mode of action or metabolism. The absence of a control group without antiresorptives means that we do not know the background rate of ONJ in cancer, so cannot make firm conclusions about the increase in ONJ incidence directly related to drug therapy.
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