@article{b03018fb6cdd4adcbe46b8e50f3baf64,
title = "Incidence, risk factors, and outcomes of osteonecrosis of the jaw: Integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases",
abstract = "Background: Osteonecrosis of the jaw (ONJ) has been reported in patients receiving bisphosphonates for metastatic bone disease. ONJ incidence, risk factors, and outcomes were evaluated in a combined analysis of three phase III trials in patients with metastatic bone disease receiving antiresorptive therapies. Patients and methods: Patients with bone metastases secondary to solid tumors or myeloma were randomly assigned to receive either s.c. denosumab (120 mg) or i.v. zoledronic acid (4 mg) every 4 weeks. On-study oral examinations were conducted by investigators at baseline and every 6 months. Oral adverse events were adjudicated by an independent blinded committee of dental experts. Results: Of 5723 patients enrolled, 89 (1.6%) patients were determined to have ONJ: 37 (1.3%) received zoledronic acid and 52 (1.8%) received denosumab (P = 0.13). Tooth extraction was reported for 61.8% of patients with ONJ. ONJ treatment was conservative in >95% of patients. As of October 2010, ONJ resolved in 36.0% of patients (29.7% for zoledronic acid and 40.4% for denosumab). Conclusions: In this combined analysis of three prospective trials, ONJ was infrequent, management was mostly conservative, and healing occurred in over one-third of the patients. Educating physicians about oral health before and during bone-targeted therapy may help reduce ONJ incidence and improve outcomes.",
keywords = "Bone metastases, Denosumab, Osteonecrosis of the jaw, Zoledronic acid",
author = "F. Saad and Brown, {J. E.} and {Van Poznak}, C. and T. Ibrahim and Stemmer, {S. M.} and Stopeck, {A. T.} and Diel, {I. J.} and S. Takahashi and N. Shore and Henry, {D. H.} and Barrios, {C. H.} and T. Facon and F. Senecal and K. Fizazi and L. Zhou and A. Daniels and P. Carri{\`e}re and R. Dansey",
year = "2012",
month = may,
doi = "10.1093/annonc/mdr435",
language = "אנגלית",
volume = "23",
pages = "1341--1347",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Elsevier Ltd.",
number = "5",
}