Adjudication of osteonecrosis of the jaw in phase III randomized controlled trials of denosumab: a systematic review.

Fiche publication

Date publication

mai 2017

Journal

European journal of clinical pharmacology

Auteurs

Membres identifiés du Cancéropôle Est :
Pr MAHMOUDI Abd-El-Rachid

Tous les auteurs :
de Boissieu P, Kanagaratnam L, Mahmoudi R, Morel A, Dramé M, Trenque T

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/28188332

Résumé

Denosumab (an anti RANKL antibody) is known to be associated with an increased risk for osteonecrosis of the jaw (ONJ). Due to the variety of clinical presentation, many ONJ definitions are used. Evaluation of ONJ's frequency during phase III randomized controlled trials (RCTs) is crucial to assess benefit-risk ratio. We verified that phase III RCTs involving denosumab reported the definition of ONJ used.