Information – BETCON

Medication related osteonecrosis of the jaw (MRONJ)

Medication related osteonecrosis of the jaw (MRONJ) is a side-effect of bone modifying agents (BMA), a class of drugs that target osteoclast function in bone and include bisphosphonates (e.g. pamidronate, ibandronate, zoledronic acid) and denosumab (a monoclonal antibody targeting RANK-ligand).

MRONJ has been defined as the persistence of exposed bone in the oral cavity, despite an adequate treatment for 8 weeks, without local evidence of malignancy and no prior radiotherapy to the affected region. Typically, patients suffer from pain and signs of infection, including bad breath, swelling, purulent discharge, difficulty eating, and may develop fistulas to the skin or sinuses, and pathologic fracture of the jaw bone.

Almost 15 years after the first reports of MRONJ, it remains notoriously difficult to treat and there is still no defined treatment algorithm. Current treatment guidelines for MRONJ advocate that management should focus on control of infection, pain and progression of bone necrosis, with a stage specific approach where conservative treatment is used as backbone and surgical intervention reserved for higher disease stages.(3, 10, 11) Nevertheless, there is considerable heterogeneity in the literature regarding the outcomes of conservative treatment beyond the earliest stages of MRONJ. Further studies to elucidate the best treatment protocols for MRONJ are needed.

BETCON study

BETCON is a comparative effectiveness research (CER) study that will test the hypothesis that adding minimally invasive treatment with LPRF membranes or primary surgical treatment to the standard of care consisting of conservative treatment alone is superior to achieve mucosal healing in patients with newly diagnosed stage I-II MRONJ.

More details on the design of the study are available on Clinicaltrials.gov (NCT04512638).