Arduino, Paolo Giacomo

Cabras, Marco

Caka, Majlinda

Carossa, Massimo

Dell'Acqua, Alessandro

Fasciolo, Antonella

Franchi, Stefano

Gambino, Alessio

Garzino Demo, Paolo

Giordano, Lia

Pentenero, Monica

Ramieri, Guglielmo

English

Institutional Research Information System University of Turin

Open Peer Review on QeiosOSTEONECROSIS OF JAW (ONJ) IN PATIENTS WITHOSTEOPOROSIS AND OTHER NON-MALIGNANTDISEASES IN PIEDMONT AND AOSTA VALLEY 2004-2018Alessio Gambino1, MARCO CABRAS1, Francesco Maria Erovigni1, Alessandro Dell'Acqua2, FRANCESCO DELLAFERRERA3, Paolo Appendino3, Stefano Franchi4, Majlinda Caka5, Antonella Fasciolo6, Mario Migliario7, GuglielmoRamieri1, Paolo Garzino Demo1, Monica Pentenero1, lia giordano1, Massimo Carossa1, Paolo Giacomo Arduino1, VittorioFusco61 University of Turin2 A.O.U. Citta della Salute e della Scienza di Torino3 Azienda Ospedaliera Ordine Mauriziano di Torino4 University of Eastern Piedmont5 Azienda Sanitaria Locale Asti6 Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo7 Amedeo Avogadro University of Eastern PiedmontFunding: The author(s) received no specific funding for this work.Potential competing interests: The author(s) declared that no potential competing interests exist.AbstractOsteonecrosis of the Jaws (ONJ) related to bisphosphonates (BPs) or denosumab is a concern for osteoporosis andRheumatoid Arthritis (RA) patients. In a context of increasing prescription rate of BPs and denosumab amid thosepatients in the last decade, incidence and/or prevalence of ONJ in these categories of patients remain uncertain, withlack of solid epidemiologic data from observational studies. As an almost unique experience, the present work providesa multicenter, retrospective overview of ONJ in non malignant disease patients over a timespan of 15 years (Jan 1st2004 - Dec 31st, 2018) from the oral care centers of Piedmont and Valle d’Aosta.  In detail, data from 165 patients (8 M,157 F) were acquired. Mean age was of 74 (38-91) years, with more than half (64.2%) of patients diagnosed with ONJQeios, CC-BY 4.0   ·   Article, April 12, 2021Qeios ID: RFSJ8T   ·   https://doi.org/10.32388/RFSJ8T 1/3between 70 and 89 years. Underlying diseases were osteoporosis (80%), RA (5.4%), osteoporosis and RA (3.6%), otherbone disorders (11%). Treatment administered were alendronate (51.8%), ibandronate (12.3%), zoledronic acid (6.8%),others (29.1%). Concerning the latter, since 2014, 7 cases were related to denosumab (60 mg every 6 months), of which5 to denosumab alone, 2 in patients switched from BPs to denosumab. Sites of ONJ were mandible (67%), maxilla(25%), mandible and maxilla (7%). Finally, an overall rise of ONJ occurrence was observed, with a median of 7 (2-13)yearly ONJ cases in the 2004-2010 period, gone up to 11.5 (6-24) yearly ONJ events in the 2011-2018 period. Suchworrisome trend underlines the importance of eventual prevention measures and recurring assessment of oral health toreduce ONJ risk in non-malignant disease patients. Background: Despite Osteonecrosis of Jaws (ONJ) related to bisphosphonates (BPs) or denosumab  is mostly associatedto cancer and myeloma population ([1]), it should be also considered a potential adverse effect among the increasingpopulation of patients affected by bone metabolic disorders or non-metastatic cancer, in need for BPs (oral alendronate,oral risedronate, oral/IV ibandronate, IV zoledronic acid) or subcutaneous denosumab (60 mg every 6 months) to preventfractures. With scattered epidemiologic data, incidence and prevalence of  ONJ among this population is far from being assessed,ranging from an occurrence reported as “very rare” ( [2]  ) to an observation even more frequent than ONJ in metastaticcancer patients, in absolute terms ([3]) . Aim of the present work was to retrospectively describe number of registered casesand main features of  ONJ cases observed at main hospital oral care centers, in a timespan of 15 years (2004-2018) inpatients with non-malignant diseases (primary osteoporosis, secondary osteoporosis or osteopenia, Rheumatoid Arthritisand other rheumatologic diseases) in  Piedmont and Valle d’Aosta territory (4.4 million inhabitants). Materials and Methods: Data were retrospectively collected from Oral Medicine, Oral Surgery and Oral MaxillofacialSurgery Units, from January 1st 2004 to 31st December 2018. The main parameters collected were: underlying bonemetabolic disorder (as registered in dental care charts); treatment protocol – either bisphosphonates alone, or denosumab,or bisphosphonate(s)/denosumab sequence; age of patients at year of  ONJ diagnosis;  mandibular and/or maxillary site of ONJ onset.Results: Over the 2004-2018 timespan, data from 165 patients were acquired. Of these, 95% were females. Mean age wasof 74 (38-91) years, with more than half (64.2%) of patients being diagnosed with ONJ between 70 and 89 years.Underlying disease  was reported as osteoporosis (80%), rheumatoid arthritis (5.4%), osteoporosis and rheumatoid arthritis(3.6%), or other bone disorders (11%). The bisphosphonates most commonly administered were alendronate (51.8%),ibandronate (12.3%), zoledronic acid (6.8%). Since 2014, 7 cases were related to denosumab (60 mg every 6 months),either alone (5 cases) or as part of a sequence with alendronate or ibandronate (2 cases, respectively). The remainingcases were related to clodronate, neridronate, pamidronate, and risedronate, either alone or as sequences with otherdrugs. Sites of  ONJ were mandible (67%), maxilla (25%), with maxillary and mandibular ONJ encountered in theremaining 7% . Throughout the 15 years period of investigation, an increasing trend emerged, with a median of 7 (range 2-13) yearly  ONJ cases in the 2004-2010 period, increased to 11.5 (range 6-24) yearly ONJ events in the 2011-2018 period.Conclusions:  ONJ appeared to be increasing in frequency over the last 15 years among patients affected by bonemetabolic disorders, occurring so far with predilection for mandible sites, in elderly (>70 years) and female patients, mostlyQeios, CC-BY 4.0   ·   Article, April 12, 2021Qeios ID: RFSJ8T   ·   https://doi.org/10.32388/RFSJ8T 2/3during/after bisphosphonate(s) treatment. ONJ cases solely related to denosumab were so far anecdotal, although suchfrequency might arise in the next years, due to an increasing propensity for prescription of denosumab as first-linetreatment against bone metabolic disorders, as well as a “switch” drug from protracted bisphosphonates regimens ([4])Further recollection of clinical data – concerning comorbidities, oral health risk factors, differential radiological features andsurgical outcomes – should be pursued, to clarify the main characteristics of these novel clusters of patients, emerging outof the wide population of osteoporotic elders. References1. ^Giuseppina Campisi, Stefano Fedele, Vittorio Fusco, Giuseppe Pizzo, et al. (2014). Epidemiology, clinicalmanifestations, risk reduction and treatment strategies of jaw osteonecrosis in cancer patients exposed to antiresorptiveagents. Future Oncology, vol. 10 (2), 257-275. doi:10.2217/fon.13.211.2. ^Robert A Adler, Ghada El-Hajj Fuleihan, Douglas C Bauer, Pauline M Camacho, et al. (2016). Managing Osteoporosisin Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone andMineral Research. J Bone Miner Res, vol. 31 (1), 16-35. doi:10.1002/jbmr.2708.3. ^Jeong Keun Lee et al.. (2013). Bisphosphonates-related osteonecrosis of the jaw in Korea: a preliminary report. JKorean Assoc Oral Maxillofac Surg ..4. ^Noam Yarom, Towy Sorel Lazarovici, Sara Whitefield, Tal Weissman, et al. (2018). Rapid onset of osteonecrosis ofthe jaw in patients switching from bisphosphonates to denosumab. Oral Surgery, Oral Medicine, Oral Pathology andOral Radiology, vol. 125 (1), 27-30. doi:10.1016/j.oooo.2017.09.014.Qeios, CC-BY 4.0   ·   Article, April 12, 2021Qeios ID: RFSJ8T   ·   https://doi.org/10.32388/RFSJ8T 3/3

OSTEONECROSIS OF JAW (ONJ) IN PATIENTS WITH OSTEOPOROSIS AND OTHER NON-MALIGNANT DISEASES IN PIEDMONT AND AOSTA VALLEY 2004-2018

https://iris.unito.it/bitstream/2318/2029461/1/OSTEONECROSIS%20OF%20JAW%20%28ONJ%29%20IN%20PATIENTS%20WITH%20OSTEOPOROSIS%20AND%20OTHER%20NON-MALIGNANT%20DISEASES%20IN%20PIEDMONT%20AND%20AOSTA%20VALLEY%202004-2018pdf.pdf

OSTEONECROSIS OF JAW (ONJ) IN PATIENTS WITH OSTEOPOROSIS AND OTHER NON-MALIGNANT DISEASES IN PIEDMONT AND AOSTA VALLEY 2004-2018

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