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Osteonecrosis of the jaw rare with denosumab in women with postmenopausal osteoporosis

Roshini Claire Anthony
27 Feb 2019

Postmenopausal women with osteoporosis who are treated with denosumab have a low risk of osteonecrosis of the jaw (ONJ), according to results of a recent study.

“Most ONJ cases were mild to moderate in severity and resolved with appropriate dental therapy,” said the researchers. “[D]enosumab therapy may be continued during routine oral procedures and dental care, and that the low risk of ONJ should be weighed against the previously demonstrated fracture prevention benefits of denosumab therapy in women with postmenopausal osteoporosis,” they added.

The study cohort comprised postmenopausal women (aged 60–90 years) with osteoporosis who were enrolled in the randomized, double-blind 3-year FREEDOM* (given subcutaneous denosumab 60 mg or placebo every 6 months for 3 years) and 7-year open-label FREEDOM Extension (given denosumab for 7 years; n=4,550) trials. At year 3 in the Extension trial, 3,591 women provided information (through questionnaires) on invasive oral procedures and events (OPEs)** they had experienced since the onset of the Extension trial to year 2.5 and oral events in the previous 6 months, with the questionnaires answered every 6 months until the end of the Extension trial.

A total of 1,621 women (45.1 percent) reported experiencing one or more invasive OPEs during the FREEDOM Extension study, with the incidence of each assessed event comparable between patients in the long-term (received denosumab in both FREEDOM and FREEDOM Extension) and crossover (received placebo during FREEDOM) arms (28.5 percent vs 29.1 percent for scaling/root planing, 24.6 percent vs 25.1 percent for tooth extraction, 6.0 percent vs 5.8 percent for dental implants, 4.0 percent vs 4.2 percent for natural tooth loss, and 0.9 percent in each group for jaw surgery).

There were no cases of ONJ during the FREEDOM study and 13 cases during the FREEDOM Extension study, 12 of which occurred among women who participated in the survey, and 11 of which were healed with treatment, with an average 10-month healing time. Seven of the 12 cases occurred in women in the long-term treatment arm. [J Clin Endocrinol Metab 2019;doi:10.1210/jc.2018-01965]

The rate of ONJ was 5.2 per 10,000 subject-years during the FREEDOM Extension study, with a higher risk among women who experienced invasive OPEs compared with those who did not (0.68 percent vs 0.05 percent).

Among the suggested “inciting events” for ONJ were tooth extractions in four cases and dentures in two cases, with natural tooth loss not considered an “inciting event” in the two patients who experienced it. Eight patients who experienced ONJ continued denosumab treatment, with ONJ healed in seven cases and one with ongoing ONJ lesion at study end.

“We found dental procedures were common among these patients, but … not only was ONJ rare, but the 11 cases where the outcome is known have healed,” said study lead author Dr Nelson Watts from Mercy Health in Cincinnati, Ohio, US.

The researchers highlighted the importance of routine dental care among patients with osteoporosis treated with denosumab. Among patients with a high risk for ONJ, special considerations could be taken including staged extractions for multiple extractions, prophylactic antibiotic therapy in those with a history of poor wound-healing, and ensuring dental appliances are a good fit.

“My hope is our study will help patients and oral care providers be better informed about the low risk of ONJ compared [with] the fracture prevention benefits of antiresorptive therapy in women with postmenopausal osteoporosis,” concluded Watts.

 

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