title: Prevention of bisphosphonate-related osteonecrosis of the jaws in patients with prostate cancer treated with zoledronic acid - A prospective study over 6 years.
abstract: BACKGROUND
  To explore the preventive effect of a prophylactic oral and maxillofacial treatment to reduce bisphosphonate associated necrosis of the jaws (BRONJ) in metastatic prostate cancer (PC) patients treated with zoledronic acid (4.0 mg i.v./months).
  
  
  METHODS
  253 PC patients with bone metastases were prospectively randomized. All patients received baseline assessments including a dental panoramic tomogram. Group A was monitored and treated where deemed necessary by the patient's dentist and were re-evaluated once a year. In group B patients were monitored and treated where necessary by the authors at 12 week intervals. We compared the incidence rate per year (IR) and incidence proportion (IP) in both cohorts and assessed independent risk factors for BRONJ.
  
  
  RESULTS
  Patients in group A were evaluated 3.2 (range 2-4) vs. 6.8 times (range 4-24) in group B. A significantly higher proportion of dental extractions was performed in group B vs. A (26.7% vs. 22.7%, p = 0.006). A BRONJ was detected with an IP of 23.3% vs. 2.2% in group A vs. B, revealing a 2.59 fold higher relative risk for group A (p = 0.01, 95% CI 0.01-0.56). The IR in group A was 0.073 cases/year while the IR in group B was significantly decreased by 82% to 0.0131 (p < 0.001). Extraction therapy was the only independent risk factor for BRONJ (p < 0.0001; 95% CI 21.22-189.06).
  
  
  CONCLUSIONS
  Preventive oral and maxillofacial treatment before bisphosphonate application combined with 3-monthly dental follow-ups significantly reduces the occurrence and risk of BRONJ in PC patients. Therefore this approach should be implemented in the specific treatment algorithms.
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany. Electronic address: th.mucke@gmx.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Mücke
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Herbert
authors.initials: H
authors.lastname: Deppe
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Jana
authors.initials: J
authors.lastname: Hein
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Klaus-Dietrich
authors.initials: KD
authors.lastname: Wolff
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: David A
authors.initials: DA
authors.lastname: Mitchell
authors.affiliation: Department of Oral and Maxillofacial Surgery, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Marco R
authors.initials: MR
authors.lastname: Kesting
authors.affiliation: Department of Urology, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Margitta
authors.initials: M
authors.lastname: Retz
authors.affiliation: Department of Urology, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Jürgen E
authors.initials: JE
authors.lastname: Gschwend
authors.affiliation: Department of Urology, Technische Universität München, Klinikum Rechts der Isar, Germany.
authors.forename: Mark
authors.initials: M
authors.lastname: Thalgott
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D050071:Bone Density Conservation Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000000981:diagnostic imaging / Q000517:prevention & control / Q000556:secondary; D004164:Diphosphonates / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D049268:Positron-Emission Tomography; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D011862:Radiography, Panoramic; D012307:Risk Factors; D014057:Tomography, X-Ray Computed; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid
keywords: BRONJ; Bisphosphonate; Osteonecrosis of the jaw; Prostate cancer; Zoledronic acid