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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ): A Prospective, Randomized Controlled Trial to Evaluate a Novel Non-operative Treatment

Brief 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?

Detailed Summary:

HYPOTHESES

HA: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will be different than the area of exposed bone in the standard therapy group.

H0: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will equal the area of exposed bone in the standard therapy group.

SPECIFIC AIMS

To determine if the PENTO regimen in addition to the standard of care treatment for MRONJ significantly reduces the area of exposed bone compared to standard of care alone. Standard of care is defined as the clinical guidelines of the 2014 AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw (MRONJ)

  1. Challenges: Identifying patients with Stage 1, 2, 3 MRONJ who will be compliant with therapy and available for follow-up. Measuring greatest anterior-posterior and superior-inferior dimensions to calculate area. Ensuring patient safety with interim analyses and an appropriate stopping protocol.
  2. Approach: The investigators will treat patients with Stage 1, 2, 3 MRONJ with either PENTO as an adjunct to the standard of care or standard of care alone with placebo.

Impact: >6 million patients in the US are at risk for MRONJ. If proven to successfully treat MRONJ, the trial would establish a non-operative treatment option for successful management of MRONJ with potential for significant decreased morbidity for the patient.

SAMPLE

The sample will be deriv
Sponsor: University of Washington

Current Primary Outcome: Change in Bone exposure area (mm^2) [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]

The primary lesion's area of exposed bone will be estimated by measuring the greatest anterior-posterior and superior-inferior dimensions in millimeters (mm) of the site with the largest area of exposed bone present at the time of study enrollment.

If there are multiple areas of exposed bone in a single patient, the site with the largest sum of linear anterior-posterior and superior-inferior dimensions will be included in the study.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in MRONJ Stage [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]
    MRONJ staging based on AAOMS Position paper staging criteria (Stage 0,1,2,3)
  • Change in Pain [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]
    Visual analogue scale (VAS) measure of pain. A 100 mm scale will be used with 0 = no pain and 100 = worst pain ever. The patient will be asked to indicate their level of on the VAS.
  • Change in osseous anterior-posterior linear dimension on orthopantomogram [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]
    Radiographic analysis. Greatest anterior-posterior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement.
  • Change in osseous superior-inferior linear dimension on orthopantomogram [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]
    Radiographic analysis. Dsi= Greatest superior-inferior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement.
  • Change in osseous area on orthopantomogram [ Time Frame: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months ]
    Radiographic analysis. Change in area of osseous change. Will be according to the above formulae for shape; rectangle, circle, ellipse for the orthopantomogram imaging. A 5mm ball bearing will be used to standardize the measurement.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: January 30, 2017
Date Started: February 15, 2017
Date Completion: January 2019
Last Updated: February 2, 2017
Last Verified: February 2017