The PENTO Protocol in Medication-related Osteonecrosis of the Jaw (NCT05795647) | Clinical Trial Compass
UnknownPhase 2
The PENTO Protocol in Medication-related Osteonecrosis of the Jaw
France17 participantsStarted 2024-02-29
Plain-language summary
Medication-related osteonecrosis of the jaw (MRONJ) occurs after taking bisphosphonates or targeted therapies. It leads to a significant decrease in quality of life with pain, eating and chewing disorders, and malnutrition. Current treatments are only partially effective. PENTO (pentoxifylline and tocopherol) has been shown to be effective in maxillary osteoradionecrosis. The objective of this study is to evaluate the proportion of bone recovery in patients receiving PENTO in MRONJ at 12 months.
Who can participate
Age range18 Years
SexALL
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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 (and 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 hepatic failure or renal failure (Cl \< 30 mL/min),
* Patient with hypotension (SBP \< 90 mmHg)
* Refusal to participate in the…