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The PENTO Protocol in Medication-related Osteonecrosis of the Jaw

NCT05795647 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-03-12

No results posted yet for this 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.

Conditions

  • Medication-related Osteonecrosis of the Jaw (MRONJ)

Interventions

DRUG

Pentoxifylline+Tocopherol

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

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Principal Investigators

  • Julie USSEGLIO, Dr · University Hospital, Limoges

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-04-07
Completion
2025-04-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795647 on ClinicalTrials.gov