title: Clinical course and therapeutic outcomes of operatively and non-operatively managed patients with denosumab-related osteonecrosis of the jaw (DRONJ).
abstract: OBJECTIVE
  Details regarding risk factors, onset, and outcomes for denosumab-related osteonecrosis (DRONJ) are sparse. This study examines the clinical characteristics and operative and non-operative therapeutic outcomes in patients with DRONJ not previously exposed to other antiresorptives.
  
  
  METHODS
  A retrospective medical record review was conducted, and data were collected, including clinical findings, management, healing outcomes, and radiologic, histologic, and micro-computed tomography (CT) analyses.
  
  
  RESULTS
  Seventeen patients were treated with denosumab, with 14.1 ± 8.3 doses before DRONJ onset. The majority of lesions were observed at sites of dental prostheses (41%) and dental extractions (35%). Sixteen patients were managed non-operatively (10/16) or operatively (6/16) with either major (5/6) or minor surgery (1/6) and included in the follow-up analysis. Complete healing was significant in patients treated with major surgery (80%) compared to the non-operative group (20%; p < 0.035). Denosumab was discontinued in 60% of non-operative patients and major surgery patients with no effect on healing. Histologic findings of 4 patients analyzed exhibited a decreased number of osteocyte lacunae, and micro-CT of 3 patients scanned revealed trabecular thickening.
  
  
  CONCLUSIONS
  DRONJ lesions occurred mostly at sites of prostheses sores after a mean of 14 doses of denosumab. Major surgery demonstrated more complete healing than non-operative management, and denosumab cessation did not improve healing outcomes.
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany. Electronic address: sebastian.hoefert@med.uni-tuebingen.de.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Hoefert
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Yuan
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany.
authors.forename: Adelheid
authors.initials: A
authors.lastname: Munz
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Grimm
authors.affiliation: Department of Conservative Dentistry and Periodontology, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany.
authors.forename: Ashraf
authors.initials: A
authors.lastname: Elayouti
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Hospital Tuebingen, Osianderstrasse 2-8, 72076 Tuebingen, Germany.
authors.forename: Siegmar
authors.initials: S
authors.lastname: Reinert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000175:diagnosis / Q000601:surgery / Q000628:therapy*; D050071:Bone Density Conservation Agents / Q000009:adverse effects*; D000069448:Denosumab / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: Bisphosphonates; Denosumab; Medication-related osteonecrosis of the jaw; Osteonecrosis