Reporting Criteria for Clinical Trials on Medication-Related Osteonecrosis of the Jaw (MRONJ): A Review and Recommendations
Autor: | Camille Gaudet, Stephane Odet, Christophe Meyer, Brice Chatelain, Elise Weber, Anne-Laure Parmentier, Stéphane Derruau, Sébastien Laurence, Cédric Mauprivez, Esteban Brenet, Halima Kerdjoudj, Mathilde Fenelon, Jean-Christophe Fricain, Narcisse Zwetyenga, David Hoarau, Rémi Curien, Eric Gerard, Aurélien Louvrier, Florelle Gindraux |
---|---|
Jazyk: | angličtina |
Rok vydání: | 2022 |
Předmět: | |
Zdroj: | Cells, Vol 11, Iss 24, p 4097 (2022) |
Druh dokumentu: | article |
ISSN: | 11244097 2073-4409 |
DOI: | 10.3390/cells11244097 |
Popis: | 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. |
Databáze: | Directory of Open Access Journals |
Externí odkaz: | |
Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |