SAT0365 Risk Evaluation of Osteonecrosis of the Jaw in Denosumab: Systematic Review of the Literature. (23rd January 2014) - Saule, E.
Abstract : Background: Osteonecrosis of the jaw (ONJ) is a potentially serious disease described with drugs such as bisphosphonates and denosumab. Objectives: The main objective of our study was to evaluate the risk of osteonecrosis of the jaw with denosumab in osteoporosis and update data in neoplasia. Secondary end points were to report the deadline of occurrence, the disease treated and the risk factors associated with ONJ. Methods: Systematic literature search of articles from 2004 to February 2012 with the keyword "denosumab" on the PUBMED database (Medline), selecting randomized clinical trials languages English and French. Research was expanded secondarily with cases reports. The diagnosis of ONJ had to satisfy the definition of AAOMS (American Association of oral and Maxillofacial Surgeons) and ASBMR (American Society for Bone and Mineral Research) as exposed bone in the maxillofacial region that fails to heal after appropriate intervention over a period of 8 weeks, without history of radiation therapy or bone metastasis to the jaws and should be validated by an independent expert. Results: In osteoporosis, 10 clinical trials were identified. With the dose of 60 mg every 6 months, 4 jaw osteonecrosis occurred in the FREEDOM extension study to 6 years (n = 4550) or 0.09% of patients. In neoplasia, six studies were included. With the dose of 120 mg every 4 weeks, 85 jaw osteonecrosis of 3578 patients (2.4%) occurred in the denosumab group, 26 (30%) in the first year, 72 (85%) after two years treatment. 73 patients (86%) had local risk factors, 35 (67%) had concomitant chemotherapy, 5 (16%) antiangiogenic treatment. 42 patients (49%) underwent surgical treatment limited and 5 (7%) of bone resection. Healing was achieved in 31 patients (36%). Conclusions: In neoplastic disease, osteonecrosis of the jaw is common during denosumab treatment specially if there are predisposing risk factors. In osteoporosis, it remains relatively rare. Disclosure of Interest: None Declared