Database analysis of the risk factors of bisphosphonate-related osteonecrosis of the jaw in Hungarian patients

Abstract

ObjectiveBisphosphonate-related osteonecrosis of the jaw (BRONJ) is a rare but serious side effect of bisphosphonates (BPs). Since this disease has no independent code in either of the diseases’ or in the medical procedures’ classifications, it is hard to estimate how many BP patients are affected.DesignA retrospective observational epidemiological registry-based study was carried out, using the data of the national service of Hungary on the incidence of BRONJ and related factors.SettingA data analysis was performed, which is relevant for the whole Hungarian population from 2010 to 2014. The socioeconomic and medication data of 236 207 BP patients were analysed, and a method was worked out to define BRONJ patients from the Hungarian BP population.Primary and secondary outcome measuresThe incidences of BRONJ were analysed according to genders and the types of the BP drugs administered. The marginal interdependence between the types of BP drugs, modes of administration and main indication was calculated.Results340 BP patients (0.1%) developed BRONJ. The incidence of BRONJ in Hungary in the malignant indication of BPs is 0.9%, and 0.1% in the non-malignant indication, and the OR to develop BRONJ was OR=9.7 (95% CI 7.8 to 12.1) between them. Although more women developed BRONJ, the proportion of men was significantly higher than that of women. Steroids increase the risk of jaw osteonecrosis, and differences were also found between the BP drugs.ConclusionsOncology indicated, intravenously administered and steroid comedicated BP therapies pose a high risk of developing BRONJ in the Hungarian population.

A multicenter observational study on Medication-Related Osteonecrosis of the Jaw (MRONJ) in advanced cancer and myeloma patients of a cancer network in North-Western Italy

“…Few population-based studies using clinical data from patient charts of all the observed cases have been published ( 7 - 11 ), as collection of clinically confirmed MRONJ cases outside of clinical trial settings is difficult ( 6 ). Attempts were conducted with insurance database or large national healthcare system database, but even specific algorithms showed important limitations or inconsistent results ( 12 , 13 ). Results from a large Scandinavian registry of all clinically confirmed MRONJ cases observed in three nations are awaited with great interest ( 6 , 14 ).…”

Aktualitások a gyógyszer okozta állcsontelhalás primer és szekunder prevenciójának stratégiájában az evidenciák és a nemzetközi ajánlások tükrében

“…A betegség incidenciája az alkalmazott hatóanyag(ok) típusa, a beadási mód (iv./per os), a kumulatív dózis, az alap-és kísérő betegségek, valamint a kiegészítő gyógyszeres terápiák függvényében széles határok között változik. A kialakulás valószínűsége az elérhető magyar és nemzetközi publikációk alapján a különböző betegpopulációkban több nagyságrendes eltérést is mutathat [16,17]. Az állcsontelhalás kialakulásának valószínűsége szempontjából az aktuális szakirodalom megkülönböztet "low-risk" (alacsony rizikójú) és "high-risk" (magas rizikójú) pácienseket.…”

Denosumab Versus Zoledronic Acid in the Prevention of Skeletal-related Events in Vulnerable Cancer Patients: A Meta-analysis of Randomized, Controlled Trials

“…14,15 ZA is the drug choice preferred for reducing SREs across various malignancies. However, bisphosphonate-related osteonecrosis of the jaw (ONJ) and ZA-induced renal toxicity 16,17 complicate the care of these patients. The use of ZA requires routine monitoring of renal functioning and dose adjustments, in accordance with the US Food and Drug Administration (FDA)eapproved labeling.…”