Evaluating PENTO for treating jaw bone issues from medication
The PENTO Protocol in Medication-related Osteonecrosis of the Jaw
PHASE2 · University Hospital, Limoges · NCT05795647
This study is testing a new treatment called PENTO to see if it can help people with serious jaw bone problems caused by medication feel better and heal over a year.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges (other) |
| Drugs / interventions | denosumab, bevacizumab, methotrexate |
| Locations | 1 site (Limoges) |
| Trial ID | NCT05795647 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the PENTO protocol, which combines pentoxifylline and tocopherol, in treating medication-related osteonecrosis of the jaw (MRONJ). Patients with AAOMS stage 2 MRONJ, characterized by exposed bone and significant symptoms, will receive the treatment alongside antibiotic therapy. The study will measure the proportion of bone recovery over a 12-month period, addressing the limitations of current treatments that have shown only partial effectiveness. This prospective phase IIa study seeks to provide robust evidence on the efficacy of PENTO in a larger patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a history of bisphosphonate or targeted therapy treatment and exhibit symptoms of MRONJ for more than 8 weeks.
Not a fit: Patients with a history of head or neck radiotherapy, maxilla metastases, or those currently under palliative care are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from MRONJ by promoting bone recovery and reducing pain.
How similar studies have performed: Previous studies on PENTO in related conditions have shown promise, but this approach in MRONJ is relatively novel and has not been extensively tested in larger cohorts.
Eligibility criteria
Show full inclusion / exclusion 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 (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
Where this trial is running
Limoges
- Limoges university hospital — Limoges, France (RECRUITING)
Study contacts
- Principal investigator: Julie USSEGLIO, Dr — University Hospital, Limoges
- Study coordinator: Julie USSEGLIO, Dr
- Email: julie.usseglio@chu-limoges.fr
- Phone: +33 (0) 555 056 120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Medication-related Osteonecrosis of the Jaw, MRONJ, pentoxifylline, tocophérol, bone exposure, renutrition