United Kingdom nationwide study of avascular necrosis of the jaws including bisphosphonate-related necrosis

Br J Oral Maxillofac Surg. 2015 Feb;53(2):176-82. doi: 10.1016/j.bjoms.2014.11.008. Epub 2014 Dec 11.

Abstract

We aimed to record all new patients who presented to departments of oral surgery, oral medicine, and oral and maxillofacial surgery, and to dental hospitals in the UK, with avascular necrosis of the jaws including bisphosphonate-related necrosis (BRONJ) over a 2-year period (1 June 2009-31 May 2011). They were eligible irrespective of age, cause, or coexisting conditions. Data on incidence, clinical characteristics, risk factors, and coexisting conditions were collected. A total of 383 cases were registered: 369 were described as BRONJ, 5 as avascular necrosis, and 9 were unknown. Bisphosphonates had been given orally in 207 (56%), intravenously in 125 (34%), both orally and intravenously in 27 (7%), and was unknown in 9 (2%); one had been given denosumab. The main risk factor was dental extraction, and the mandible was commonly affected. The median duration of administration until onset of BRONJ was 3 years in those treated intravenously and 4 years in those treated orally. Levels of engagement with the study varied between regions, and extrapolation from the 2 most involved (Merseyside and Northern Ireland) found around 8.2-12.8 cases/million/year, which is 508-793 patients/year across the UK. To our knowledge this is one of the first studies to estimate national rates of BRONJ. It confirms that the risk and incidence are low. With changes in trends for antiresorptive bone medication, and increasing numbers of elderly people, it would be useful to repeat the registration in the future.

Keywords: Bisphosphonates; Cancer; Jaw necrosis; National incidence; Osteoporosis; Pharmacovigilance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Administration, Oral
  • Adrenal Cortex Hormones / therapeutic use
  • Aged
  • Aged, 80 and over
  • Alcohol Drinking / epidemiology
  • Bisphosphonate-Associated Osteonecrosis of the Jaw / epidemiology*
  • Bone Density Conservation Agents / administration & dosage
  • Chronic Disease
  • Diphosphonates / administration & dosage
  • Female
  • Humans
  • Incidence
  • Jaw Diseases / epidemiology*
  • Longitudinal Studies
  • Male
  • Mandibular Diseases / epidemiology
  • Middle Aged
  • Neoplasms / drug therapy
  • Osteonecrosis / epidemiology*
  • Osteoporosis / drug therapy
  • Prospective Studies
  • Risk Factors
  • Smoking / epidemiology
  • Time Factors
  • Tooth Extraction / statistics & numerical data
  • United Kingdom / epidemiology

Substances

  • Adrenal Cortex Hormones
  • Bone Density Conservation Agents
  • Diphosphonates