Interventions for treating bisphosphonate-related osteonecrosis of the jaw (BRONJ)

• Published in: Cochrane database of systematic reviews 2016-02, Vol.2 (2), p.CD008455
• Main Authors: Rollason, Victoria, Laverrière, Alexandra, MacDonald, Laura C I, Walsh, Tanya, Tramèr, Martin R, Vogt-Ferrier, Nicole B
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - therapeutic use; Bisphosphonate-Associated Osteonecrosis of the Jaw - surgery; Bisphosphonate-Associated Osteonecrosis of the Jaw - therapy; Child health; Combined Modality Therapy - methods; Dentistry & oral health; Humans; Hyperbaric Oxygenation - methods; Mouthwashes - therapeutic use; ORAL HEALTH; Pain Measurement; Randomized Controlled Trials as Topic; Standard of Care; Time Factors
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD008455.pub2

Bisphosphonate drugs can be used to prevent and treat osteoporosis and to reduce symptoms and complications of metastatic bone disease; however, they are associated with a rare but serious adverse event: osteonecrosis of the maxillary and mandibular bones. This condition is called bisphosphonate-related osteonecrosis of the jaw or BRONJ. BRONJ is diagnosed when people who are taking, or have previously taken, bisphosphonates have exposed bone in the jaw area for more than eight weeks in the absence of radiation treatment. There is currently no "gold standard" of treatment for BRONJ. The three broad categories of intervention are conservative approaches (e.g. mouth rinse, antibiotics), surgical interventions and adjuvant non-surgical strategies (e.g. hyperbaric oxygen therapy, platelet-rich plasma), which can be used in combination. To determine the efficacy and safety of any intervention aimed at treating BRONJ. We searched the following databases to 15 December 2015: the Cochrane Oral Health Group Trials Register, the Cochrane Breast Cancer Group Trials Register (20 September 2011), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, EMBASE via Ovid, CancerLit via PubMed, CINAHL via EBSCO and AMED via Ovid. We scanned the references cited in retrieved articles and contacted experts in the field, the first authors of included papers, study sponsors, other bisphosphonates investigators and pharmaceutical companies. We searched for ongoing trials through contact with trialists and by searching the US National Institutes of Health Trials Register (clinicaltrials.gov) and the World Health Organization Clinical Trials Registry Platform. We also conducted a grey literature search to September 2015. Randomised controlled trials (RCTs) comparing the effects of any treatment for BRONJ with another treatment or placebo. Two review authors independently screened the search results, assessed the risk of bias in the included trials and extracted data. When in dispute, we consulted a third review author. One small trial at high risk of bias met the inclusion criteria. The trial randomised 49 participants, most of whom had cancer. It compared standard care (defined as surgery, antibiotics and oral rinses at the discretion of the oral-maxillofacial surgeon) to standard care plus hyperbaric oxygen therapy (2 atmospheres twice a day for 40 treatments). The trial measured the percentage of participants who improved or healed at three, six, 12 and