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Azienda Ospedaliera Nazionale“SS. Antonio e Biagio e Cesare Arrigo”Working Paper of Public Healthnr. 12/2012after BP discontinuation [42], BRONJ in a hemodialysis patient [43], ONJ in a leukaemiapatient not treated with BPs [44], BRONJ associated with photodynamic therapy [45].BRONJ incidence (or prevalence, or frequency) data have been evaluated and discussed byItalian authors : in breast cancer patients [27,33,46-47], in prostate cancer patients [48-49] , inmyeloma patients [50-54] , and in mixed neoplasms patient series [54-57] .Large (more than 100 BRONJ cases) single-centre experiences have been published, such asthat of Parma [58] and Catania [59] , or are under reviewing (e.g.Verona, Palermo, Rome,Milan, etc).One regional experience (247 cases in Piemonte-Valle d’Aosta area, on years 2005-2008) hasbeen published only as a summary, at this date [56, 60] .A multicenter case collection of 672 BRONJ cases observed in several Italian centers,collected on 2009, is under evaluation and has generated one published article [61] and otherpapers under authors’ discussion or under submission.ONJ definition and staging were examined by several Italian researchers, who underlinedproblems concerning cases without bone exposure and the so-called “stage 0 ” according tothe AAOMS staging system [62-63] ; a proposal for a new staging system is underdiscussion by members of a panel prompted by Italian societies of maxillofacial surgeons(SICMF) and oral care specialists (SIPMO).Imaging studies have been performed [64-69] and others are submitted or ongoing.Risk factors are fundamental to know odd ratio of single patients. Systemic risk factors, suchas type of BP (with zoledronic acid linked to higher risk) [46, 53] and treatment durationand schedule [53,70-72] have been studied; after-treatment residual risk was reported [42].Local (dental) risk factors, including tooth extractions [70] , periodontal disease [25] , anddental implant [73-75] have been underlined.About preventive measures, Italian authors published proposals of risk management [76-84]but also efficacy studies [85-86] and general population evaluations [60].Dental extraction protocols in BP-exposed patients have been reported by several groups [12,75, 87-89] in order to minimize the risk of ONJ after dentoalveolar trauma.BRONJ in non-malignant diseases, mostly osteoporosis patients, was critically evaluated[80,82, 90-91] , with increased reports in latest years [73, 92-94]; Italian authors wereincluded in an international multi-centre study [95] .4
Azienda Ospedaliera Nazionale“SS. Antonio e Biagio e Cesare Arrigo”Working Paper of Public Healthnr. 12/2012Reports and evaluations by Italian authors about ONJ in patients receiving other drugs (withor without BPs) have been published; they included bevacizumab [47, 96], sunitinib [97-98], denosumab [10] .Uncertainty of efficient BRONJ treatment options was examined by several Italian groups[39, 55, 61, 99- 101]. Conservative treatments were indicated as fundamental by someauthors [59, 93, 102-103] . Surgical treatment series or case reports have been object ofseveral papers [61,104-111] , including a prospective experience of large jaw resections withlong-term follow-up [112] .The first case of autologous bone marrow stem cell intralesional transplantation to repairBRONJ has been recently published by an Italian centre [113] .Laser therapy, with different instruments, was proposed by several groups [114-119] .Also ozone therapy has been applied in different forms [120-123] , and comparison studiesare needed to confirm its usefulness.Italian language publicationsIn years 2004-2011, at least 84 Italian language articles (reviews, case reports, case series)and abstracts have been published (mostly in dentist Italian literature, but often on websitesor web journals), even from physicians and centres not publishing on Pub Med journals .Two Italian language books [124-125] and the translation of a textbook by RE Marx [126]have been printed.AIFA reportsSince 2005, numerous reports from AIFA (the Italian Drug Surveillance Agency) includedONJ case series and prevention recommendations. However only a little part of ONJ casespublished in literature and/or reported at congresses and conferences are also signalled to theAgency, due to a poor attitude of Italian physicians and dentists to centralized drug sideeffectreporting (only 425 BRONJ cases had been reported to the national Drug SurveillanceSystem as of June 2009) [127].The AIFA offices actively worked with European Agency (EMEA, now EMA) on discussingONJ phenomenon [128], both related to BP treatment and to other drugs (antiangiogenicagents) [129], collaborating on releasing of bevacizumab and sunitinib alerts on autumn2010 [130, 131, 132] .5
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