87RI21_0052 (PENTO)

About this trial

Last updated 2 years ago

Study ID

87RI21_0052 (PENTO)

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 4 months ago

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.

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

The PENTO Protocol in Medication-related Osteonecrosis of the Jaw