| アブストラクト | INTRODUCTION: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) have been characterized with the use of oral bisphosphonates in osteoporosis and zoledronate in oncology. Uncertainties remain, though, with the occurrence of BRONJ related to the use of zoledronate in osteoporosis. OBJECTIVES: We aimed to estimate the incidence and characterize the risk factors of zoledronate-associated BRONJ in osteoporosis as compared with oral bisphosphonates in real life setting. METHODS: Cases of BRONJ associated with zoledronate, alendronate or risedronate were extracted from the French pharmacovigilance database up to 2020. The incidence of BRONJ was estimated as their respective numbers related to cases of BRONJ in patients treated with bisphosphonates for osteoporosis, over the same period, according to the Medic'AM database. RESULTS: Between 2011 and 2020, BRONJ incidence with zoledronate was 9.6/100,000 patient-year (PY), significantly higher than with alendronate (5.1/100,000 PY, P<0.001), and risedronate (2.0/100,000 PY, P<0.001). The number of patients treated with bisphosphonates has steadily decreased by 44.5% over 10 years. Meanwhile, the incidence of BRONJ decreased (5.8/100,000 PY in 2011; 1.5/100,000 in 2020), although a rebound was observed in 2018, including 47.6% of BRONJ following denosumab. Apart from classical risk factors, recent dental cares stood out in more than 40% of BRONJ, and zoledronate had a shorter exposure time than oral bisphosphonates. CONCLUSIONS: In a real-life setting, our data confirm that zoledronate-associated BRONJ in osteoporosis is scarce, seeming slightly more common compared with oral bisphosphonates. We also raise awareness of dental care guidelines and greater vigilance when using bisphosphonates in patients with previous exposure to denosumab. |
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| 投稿者 | Amigues, Claire; Fresse, Audrey; Roux, Christian Hubert; Gauthier, Sophie; Vieillard, Marie-Helene; Drici, Milou-Daniel; Breuil, Veronique |
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| 組織名 | Universite Cote d'Azur (UCA), service de rhumatologie, CHU de Nice, hopital;Pasteur 2, 30, voie Romaine, CS 51069, 06001 Nice cedex 1, France.;Universite Cote d'Azur Medical Center, Department of Pharmacology, Nice, France.;CHU de Lille, Pharmacology Department, centre regional de pharmacovigilance,;university Lille, 59000 Lille, France.;CHU de Lille, Department of Rheumatology, University Lille, 59000 Lille, France;;Oscar Lambret Cancer Center, Lille, France; CANTHER, Team Target UMR 9020 CNRS,;UMR-S 1277 Inserm, universite de Lille, institut Pasteur de Lille, Lille, France.;Pasteur 2, 30, voie Romaine, CS 51069, 06001 Nice cedex 1, France; Universite;Cote d'Azur (UCA), UMR E-4320 MATOs CEA/iBEB/SBTN, faculte de medecine, 28,;avenue de Valombrose, 06107 Nice cedex 2, France. Electronic address:;breuil.v@chu-nice.fr. |
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