Osteonecrosis Clinical Trials

Find Osteonecrosis Clinical Trials Near You

The PENTO Protocol in Medication-related Osteonecrosis of the Jaw

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than or equal to 18 years

• Current or past treatment with bisphosphonates (oral or IV) and/or targeted therapies (denosumab, bevacizumab)

• Signs and symptoms for more than 8S with confirmation that the signs and symptoms are not of dental origin

• AAOMS Stage 2 MRONJ

• For patients of childbearing age, effective contraception is required

Locations
Other Locations
France
Limoges university hospital
RECRUITING
Limoges
Contact Information
Primary
Julie USSEGLIO, Dr
julie.usseglio@chu-limoges.fr
+33 (0) 555 056 120
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2028-04-07
Participants
Target number of participants: 17
Treatments
Experimental: Pentoxifylline
Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Limoges

This content was sourced from clinicaltrials.gov