drugset / Trial / NCT05795647

The PENTO Protocol in Medication-related Osteonecrosis of the Jaw

NCT05795647

Phase 2 Recruiting 17 enrolled University Hospital, Limoges
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-02-29
Primary completion
2027-04-07
Completion
2028-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pentoxifylline Small molecule 400 mg
Subject Vitamin E Other / unclassified 500 mg