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The PENTO Protocol in Medication-related Osteonecrosis of the Jaw

Study acronym: PENTO
StatusRecruiting
PhasePhase 2
Started2024-02-29
View on ClinicalTrials.gov ↗

Amendment history

2026-06-23
Study Status v4
Primary completion date2025-04-07→2027-04-07
Completion date2025-04-07→2028-04-07
2024-03-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-02-01→2025-04-07
Completion date2025-02-01→2025-04-07
Start dateestimated 2023-11-20→confirmed 2024-02-29
Study sites0→1
2023-10-26
Study Status, Eligibility v2
Start date2023-09-01→2023-11-20
Eligibility criteria-64 characters
[...] tion to penicillins, cephalosporins, or other beta-lactams (orand clindamycin or lincomycin if applicable) or excipient of am [...] drugs, macrolide or streptogramin antibiotics Patients with a history of hepatic failure, or renal failure (Cl < 30 mL/min), hypotension (SBP (systolic blood pressure) < 90 mmHg) Patient with hypotension (SBP < 90 mmHg) Refusal to partici [...]
2023-05-30
Study Status v1
Start date2023-05-01→2023-09-01
2023-03-20
Original filing
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.
Trial Details
NCT Number NCT05795647
Lead Sponsor University Hospital, Limoges
Conditions Medication-related Osteonecrosis of the Jaw (MRONJ)
Enrollment 17 participants
Start Date 2024-02-29
Primary Completion 2027-04-07 (estimated)
Study Completion 2028-04-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-24