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Recruiting Phase 2

The PENTO Protocol in Medication-related Osteonecrosis of the Jaw

NCT05795647 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-02-29
Last updated
2026-06-24

Condition(s) studied

Medication-related Osteonecrosis of the Jaw (MRONJ)

Investigational drug(s) / intervention(s)

Pentoxifylline+TocopherolAll Pentoxifylline trials (10) →All Tocopherol trials (2) →

Pentoxifylline+Tocopherol: Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Exposure bone area (EBA) — Month 12
    exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA \< 5 mm) at 12 months.

Trial sites (1)

FacilityCityRegionStatus
Limoges university hospital Limoges France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05795647 on ClinicalTrials.gov ↗ ← All trials in France