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Study on the Effects of Pentoxifylline, Retinol Acetate, and DL-Alpha Tocopherol Acetate for Patients with Medication-Related Osteonecrosis of the Jaw

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What is this study about?

This clinical trial is focused on studying a condition known as Medication-Related Osteonecrosis of the Jaw (MRONJ). This condition can occur in patients who have been treated with certain medications, such as bisphosphonates or targeted therapies like denosumab and bevacizumab, which are often used to treat bone-related conditions or cancer. The trial will explore the effectiveness of a treatment protocol called PENTO, which includes the use of medications like pentoxifylline, retinol acetate (also known as Vitamin A acetate), and dl-alpha tocopherol acetate (Vitamin E). These medications are taken orally, meaning they are swallowed in pill form.

The purpose of this study is to assess how well the PENTO treatment helps in healing the jawbone in patients with MRONJ over a period of 12 months. Participants in the study will receive the PENTO treatment and will be monitored regularly to see if the area of exposed bone in the jaw becomes smaller, ideally less than 5 millimeters, which would indicate healing. The study will also track changes in the participants’ overall health, including their weight, body mass index (BMI), and levels of certain proteins in the blood that are indicators of nutrition.

Throughout the study, participants will have follow-up visits at 1, 3, 6, and 12 months to monitor their progress. During these visits, any side effects or adverse events will be recorded, and the severity of these events will be assessed. The study aims to provide valuable information on the potential benefits of the PENTO treatment for patients suffering from MRONJ, with the hope of improving healing outcomes and overall quality of life for those affected by this condition.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on criteria such as age, past treatments, and specific symptoms related to medication-related osteonecrosis of the jaw (MRONJ).

Effective contraception is required for patients of childbearing age.

2 initial assessment

An initial assessment is conducted to measure the exposure bone area (EBA) and other health parameters like weight, BMI, and albumin levels.

The modified SOMA score, which evaluates symptoms, is also recorded.

3 medication administration

The treatment involves taking medications orally. These include retinol acetate and dl-alpha tocopherol acetate (Vitamin E), pentoxifylline, clindamycin hydrochloride, and amoxicillin sodium with clavulanic acid.

The specific dosage and frequency of these medications are determined by the healthcare provider.

4 follow-up visits

Follow-up visits are scheduled at 1, 3, 6, and 12 months to monitor progress.

During these visits, the EBA is measured again, and the modified SOMA score and nutritional parameters are reassessed.

Any adverse events are recorded, including their nature and severity.

5 final assessment

At the 12-month mark, a final assessment is conducted to determine the healing progress, defined as an EBA of less than 5 mm.

The percentage of patients achieving this level of healing is calculated.

Who Can Join the Study?

  • Age must be 18 years or older.
  • Must be currently receiving or have received in the past bisphosphonates (medications that slow down or prevent bone damage) either by mouth or through an IV, and/or targeted therapies like denosumab or bevacizumab.
  • Must have had signs and symptoms for more than 8 weeks, with confirmation that these are not due to dental issues.
  • Must be diagnosed with AAOMS Stage 2 MRONJ (a specific stage of jawbone condition).
  • If you are of childbearing age, you must use effective contraception.

Who Cannot Join the Study?

  • Patients who have a condition called medication-related osteonecrosis of the jaw cannot participate. This is a condition where the jawbone is exposed and does not heal properly, often related to certain medications.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cauexp Hhnssavuqsz Ep Ulmxhybrtomoq Dv Lppnvbx Limoges France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
29.02.2024

Trial locations

Investigated drugs:

PENTO is a combination therapy used in this clinical trial to treat a condition called Medication-Related Osteonecrosis of the Jaw (MRONJ). This condition involves the death of bone tissue in the jaw, often related to certain medications. The PENTO protocol aims to help heal the affected bone by reducing the exposed bone area to less than 5 millimeters over a period of 12 months. The therapy works by promoting bone healing and reducing inflammation, which can help improve the condition of the jawbone in patients with MRONJ.

Investigated diseases:

Medication-related osteonecrosis of the jaw – This condition involves the death of bone tissue in the jaw, often associated with the use of certain medications, particularly bisphosphonates or denosumab. It typically begins with pain, swelling, or infection of the gums and jaw, and may progress to exposed bone in the mouth. As the disease advances, patients may experience difficulty eating, speaking, or maintaining oral hygiene. The progression can lead to more significant bone exposure and potential secondary infections. Over time, the affected area may increase, causing further complications in the oral cavity. The condition requires careful monitoring to manage symptoms and prevent further deterioration.

Trial ID:
2024-518688-36-00
Protocol code:
87RI21_0052
NCT ID:
NCT05795647
Trial Phase:
Therapeutic exploratory (Phase II)

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