Reporting Criteria for Clinical Trials on Medication-Related Osteonecrosis of the Jaw (MRONJ): A Review and Recommendations

Cells. 2022 Dec 16;11(24):4097. doi: 10.3390/cells11244097.

Abstract

Medication-related osteonecrosis of the jaw (MRONJ) is a complication caused by anti-resorptive agents and anti-angiogenesis drugs. Since we wanted to write a protocol for a randomized clinical trial (RCT), we reviewed the literature for the essential information needed to estimate the size of the active patient population and measure the effects of therapeutics. At the same time, we designed a questionnaire intended for clinicians to collect detailed information about their practices. Twelve essential criteria and seven additional items were identified and compiled from 43 selected articles. Some of these criteria were incorporated in the questionnaire coupled with data on clinical practices. Our review found extensive missing data and a lack of consensus. For example, the success rate often combined MRONJ stages, diseases, and drug treatments. The occurrence date and evaluation methods were not harmonized or quantitative enough. The primary and secondary endpoints, failure definition, and date coupled to bone measurements were not well established. This information is critical for writing a RCT protocol. With this review article, we aim to encourage authors to contribute all their findings in the field to bridge the current knowledge gap and provide a stronger database for the coming years.

Keywords: anti-angiogenic; bisphosphonates; bone healing; consensus; denosumab; oral mucosa; osteonecrosis; tools.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Angiogenesis Inhibitors
  • Bisphosphonate-Associated Osteonecrosis of the Jaw* / drug therapy
  • Bone Density Conservation Agents* / adverse effects
  • Diphosphonates
  • Humans
  • Knowledge
  • Randomized Controlled Trials as Topic

Substances

  • Angiogenesis Inhibitors
  • Bone Density Conservation Agents
  • Diphosphonates

Grants and funding

This study was supported by a grant from the French Ministry of Health (PHRCI-20-036).