Rates of Osteonecrosis of the Jaw Low for Denosumab-Treated Women
Invasive oral procedures associated with increased incidence of ONJ, but rate low overall
THURSDAY, Feb. 14, 2019 (Pharmacist's Briefing) -- For denosumab-treated women with postmenopausal osteoporosis, invasive oral procedures and events (OPEs), including dental implants, tooth extraction, natural tooth loss, scaling/root planning, and jaw surgery, are common and associated with osteonecrosis of the jaw (ONJ), although the overall rate of ONJ is low, according to a study published online Feb. 13 in the Journal of Clinical Endocrinology & Metabolism.
Nelson B. Watts, M.D., from Mercy Health in Cincinnati, and colleagues examined information on OPEs during the seven-year FREEDOM Extension, in which women with postmenopausal osteoporosis received open-label denosumab after the three-year placebo-controlled FREEDOM trial. At extension year 3, women were asked to record their history of invasive OPEs since the start of the extension to year 2.5 and oral events in the previous six months; the questionnaire was administered every six months until the end of the extension.
The researchers found that 45.1 percent of the respondents reported one or more invasive OPEs. In the FREEDOM Extension, the exposure-adjusted ONJ rate was 5.2 per 10,000 subject-years. Those reporting an OPE had higher incidence of ONJ than those not reporting an OPE (0.68 versus 0.05 percent). All cases of ONJ with complete follow-up resolved after treatment.
"My hope is our study will help patients and oral care providers be better informed about the low risk of ONJ compared to the fracture prevention benefits of antiresorptive therapy in women with postmenopausal osteoporosis," Watts said in a statement.
Several authors disclosed financial ties to the pharmaceutical industry.