ZOLEDRONATE-RELATED OSTEONECROSIS OF THE JAW IN OSTEOPOROSIS: INCIDENCE, RISK FACTORS AND COMPARISON TO ORAL BISPHOSPHONATES
Authors: C. Amigues C et a., France
This observational study from the French pharmacovigilance database aimed to define the incidence of osteonecrosis of the jaw (ONJ) due to medication with the bisphosphonates zoledronate, risedronate and alendronate. Additionally, risk factors analyzed for ONJ were age, sex, active smoking, alcoholism, diabetes, corticotherapy, neoplasia, previous treatment by chemo- or immunotherapy, recent dental care and time of exposure to BP.
Between 2011 and 2020, 614 932 patients were treated with zoledronate with 59 cases of ONJ reported yielding an incidence of 9.6/100,000 person-years; 2 233 536 patients were treated with risedronate with 44 cases of ONJ reported yielding an incidence of 2.0/100 000 person-years; 2 432 373 patients were treated with alendronate and 125 cases of ONJ reported yielding an incidence of 5.1/100 000 person-years.
Risk factors for ONJ were recent dental care, age ≥ 65 years, smoking, corticotherapy, history of neoplasia and chemotherapy.
This observational study confirms in real-life settings and a large population, that bisphosphonate related ONJ is a rare event in patients with osteoporosis. The risk appears to be related to the potency of bone resorption inhibition, as risedronate has the lowest and zoledronate the highest risk. The usual limitations of pharmacovigilance studies are their retrospective nature and the common underreporting of adverse events.