The PENTO Protocol in Medication-related Osteonecrosis of the Jaw (PENTO)
Medication-related Osteonecrosis of the Jaw (MRONJ)
About this trial
This is an interventional treatment trial for Medication-related Osteonecrosis of the Jaw (MRONJ) focused on measuring MRONJ, pentoxifylline, tocophérol, bone exposure, renutrition
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years Current or past treatment with bisphosphonates (oral or IV) and/or targeted therapies (denosumab, bevacizumab) Signs and symptoms for more than 8S with confirmation that the signs and symptoms are not of dental origin AAOMS Stage 2 MRONJ For patients of childbearing age, effective contraception is required Exclusion Criteria: History of head or neck radiotherapy or maxilla metastases Patients who have received treatment in the past (PENTO or PENTOCLO protocol) Patients who have undergone surgery for their MRONJ within the last 3 months Pregnant or wishing to be pregnant, breastfeeding Patient under palliative care Patient with hypersensitivity to pentoxifylline or tocopherol or to an excipient History of hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactams (or clindamycin or lincomycin if applicable) or excipient of amoxicillin-a. clavulanic or clindamycin History of jaundice/hepatic injury related to amoxicillin/clavulanic acid Patient taking oral anticoagulants, or with a history of major bleeding or bleeding disorders Patient taking platelet aggregation inhibitor, theophylline or aminophylline Patient taking methotrexate, probenecid, mycophenolate mofetil, myorelaxant drugs, macrolide or streptogramin antibiotics Patients with a history of hepatic failure, renal failure (Cl < 30 mL/min), hypotension (SBP (systolic blood pressure) < 90 mmHg) Patient with hypotension (SBP < 90 mmHg) Refusal to participate in the study Patient participating in other interventional research that may interfere with the conduct of this research Patient unable to understand the protocol Patient under curatorship or guardianship
Sites / Locations
Arms of the Study
Arm 1
Experimental
Pentoxifylline
Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening