Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)

• Status: Enrolling by invitation
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: New York Center for Orthognathic and Maxillofacial Surgery; Oregon Health and Science University; University of Alabama at Birmingham; University of Michigan
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

1. Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014).

2. History of exposure to antiresorptive medications such as bisphosphonates or RANK-L inhibitors

3. Absence of tumor in the jaw at the time of recruitment

4. Patients with the capacity to give informed consent

Exclusion Criteria:

1. Patients with history of external radiation therapy to the jaws

2. Patients who underwent any surgical intervention for MRONJ in the past 4 months

3. Patients with past microvascular reconstruction of the head and neck

4. Patients with an expected survival less than 1 year

5. Patients with allergy or hypersensitivity to pentoxifylline, xanthines, or tocopherol

6. Patients with planned invasive dental procedure in the next year

7. Patients taking oral anticoagulants

8. Patients with known hemorrhagic and coagulation disorder

9. Patients with a vitamin K deficiency due to any cause

10. Female patients who are pregnant or lactating

11. Patients with history of serious bleeding or extensive retinal hemorrhage

12. Patients with ischemic heart diseases, including, but not limiting, recent myocardial infarction

13. Patients with serious cardiac arrhythmia

14. Patients with severe liver disease

15. Patients with severe renal failure (Creatinine clearance <30 mL/min)

16. Patients with diagnosed hypotension

17. Patients taking CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine)

18. Diagnosis of MRONJ with no exposed bone

19. Patient cannot tolerate impressions of exposed bone in a clinical setting, if needed.

20. There is a change in the patient's clinical presentation (tooth extraction, sequestrectomy) from alginate impression, if impression is indicated.

21. Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study

22. • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

23. Patients who are taking additional vitamin E, or you will confirm they will stop taking vitamin E if they decide to enroll in this study.

24. Patients who are taking oral anticoagulant medications.

25. Discuss with patients taking aspirin and other supplements/medications that impact coagulation to determine if the study is a good fit, and will exclude an individual whose situation or condition may interfere with safe participation in the study.