title: Osteonecrosis of the jaws in patients assuming oral bisphosphonates for osteoporosis: a retrospective multi-hospital-based study of 87 Italian cases.
abstract: BACKGROUND
  Bisphosphonates (BPs) are currently the chief drugs for the prevention/treatment of osteoporosis; one of their adverse effects is the osteonecrosis of the jaw (BRONJ). The primary endpoints of this multi-center cross-sectional study are: i) an observation of the clinical features of BRONJ in 87 osteoporotic, non-cancer patients; and ii) an evaluation of their demographic variables and comorbidities.
  
  
  METHODS
  87 BRONJ patients in therapy for osteoporosis with BPs from 8 participating clinical Italian centers were consecutively identified and studied. After BRONJ diagnosis and staging, comorbidities and data relating to local and drug-related risk factors for BRONJ were collected.
  
  
  RESULTS
  77/87 (88.5%) patients in our sample used alendronate as a BP type; the duration of bisphosphonate therapy ranged from 2 to 200 months, and 51.7% of patients were in treatment for ≤ 38 months (median value). No comorbidities or local risk factors were observed in 17 (19.5%) patients, indicating the absence of cases belonging to BRONJ forms triggered by surgery. BRONJ localization was significantly associated with age: an increased risk of mandible localization (p=0.002; OR=6.36, 95%CI=[1.89; 21.54]) was observed for those over 72 yrs. At multivariate analysis, the increased risk of BRONJ in the mandible for people over 72 yrs (OR'=6.87, 95%CI=[2.13; 2.21]) was confirmed for a BP administration >56 months (OR'=4.82, 95%CI=[2.13; 22.21]).
  
  
  CONCLUSIONS
  Our study confirms the fundamental necessity of applying protocols of prevention in order to reduce the incidence of BRONJ in osteoporotic, non-cancer patients in the presence of comorbidities and/or local risk factor as well as, less frequently, in their absence.
authors.affiliation: Department of Surgical, Oncological and Oral Sciences, Sector of Oral Medicine "V. Margiotta", University of Palermo, Via del Vespro 129, 90127 Palermo, Italy.
authors.forename: Olga
authors.initials: O
authors.lastname: Di Fede
authors.forename: Vittorio
authors.initials: V
authors.lastname: Fusco
authors.forename: Domenica
authors.initials: D
authors.lastname: Matranga
authors.forename: Luigi
authors.initials: L
authors.lastname: Solazzo
authors.forename: Mario
authors.initials: M
authors.lastname: Gabriele
authors.forename: Giovanni M
authors.initials: GM
authors.lastname: Gaeta
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Favia
authors.forename: Delia
authors.initials: D
authors.lastname: Sprini
authors.forename: Franco
authors.initials: F
authors.lastname: Peluso
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colella
authors.forename: Paolo
authors.initials: P
authors.lastname: Vescovi
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Campisi
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000009:adverse effects; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000009:adverse effects; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000209:etiology* / Q000473:pathology; D050071:Bone Density Conservation Agents / Q000009:adverse effects*; D003430:Cross-Sectional Studies; D003920:Diabetes Mellitus; D004164:Diphosphonates / Q000009:adverse effects*; D005260:Female; D006331:Heart Diseases / Q000150:complications; D006801:Humans; D006973:Hypertension / Q000150:complications; D007558:Italy; D008107:Liver Diseases / Q000150:complications; D008334:Mandible / Q000473:pathology; D008875:Middle Aged; D015999:Multivariate Analysis; D010024:Osteoporosis / Q000139:chemically induced / Q000188:drug therapy; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000305:Adrenal Cortex Hormones; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D019386:Alendronate
keywords: Oral bisphopshonates; Osteonecrosis jaws; Osteoporosis