Medication-related Osteonecrosis of the Jaw (MRONJ)Phase 2PENTONCT05795647
The PENTO Protocol in Medication-related Osteonecrosis of the Jaw
A Phase 2 study testing Pentoxifylline+Tocopherol in people with Medication-related Osteonecrosis of the Jaw (MRONJ), run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication-related Osteonecrosis of the Jaw (MRONJ)
- What is being tested?
- Pentoxifylline+Tocopherol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 29 Feb 2024to 7 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of head or neck radiotherapy or maxilla metastases
- Patients who have received treatment in the past (PENTO or PENTOCLO protocol)
- Patients who have undergone surgery for their MRONJ within the last 3 months
- Pregnant or wishing to be pregnant, breastfeeding
- Patient under palliative care
- Patient with hypersensitivity to pentoxifylline or tocopherol or to an excipient
Show all 17Show fewer
- History of hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactams (and clindamycin or lincomycin if applicable) or excipient of amoxicillin-a. clavulanic or clindamycin
- History of jaundice/hepatic injury related to amoxicillin/clavulanic acid
- Patient taking oral anticoagulants, or with a history of major bleeding or bleeding disorders
- Patient taking platelet aggregation inhibitor, theophylline or aminophylline
- Patient taking methotrexate, probenecid, mycophenolate mofetil, myorelaxant drugs, macrolide or streptogramin antibiotics
- Patients with hepatic failure or renal failure (Cl < 30 mL/min),
- Patient with hypotension (SBP < 90 mmHg)
- Refusal to participate in the study
- Patient participating in other interventional research that may interfere with the conduct of this research
- Patient unable to understand the protocol
- Patient under curatorship or guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Limoges university hospital
Limoges, 87042
Julie USSEGLIO, MD, julie.usseglio@chu-limoges.fr
Julie USSEGLIO, MD
About this study
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.
Read the detailed description
MRONJ is defined as intraoral bone exposure persisting for more than 8 weeks after taking an anti-resorptive agent (per os or IV bisphosphonates, targeted therapies) and without history of maxilla radiotherapy or metastasis. It leads to a significant decrease in quality of life with significant pain at rest and during mastication, and compromised nutrition, sometimes resulting in severe undernutrition in patients already weakened by a history of cancer. Current treatments (prolonged antibiotic therapy, repeated bone curettage) have shown partial effectiveness. PENTO (combination of pentoxifylline, a vasodilator, and tocopherol, vitamin E) has been shown to significantly reduce intraoral exposed bone surface area and pain in maxilla osteoradionecrosis. All studies conducted so far on PENTO in MRONJ are retrospective or involve small samples. Therefore, our idea is to perform a well-conducted prospective phase IIa study to prove the efficacy of PENTO, with a larger sample size and identical follow-up periods. The investigators will study patients with AAOMS stage 2 MRONJ (exposed bone in symptomatic patients, without pathologic fracture).
Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening. Antibiotic therapy with Augmentin (or clindamycin) will be added for the first month and then punctually if signs of local infection appear.
The primary and secondary endpoints will be assessed at inclusion and at 1, 3, 6 and 12 months.
- Being tested
- Pentoxifylline+Tocopherol
- Keywords
- MRONJ, pentoxifylline, tocophérol, bone exposure, renutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline+TocopherolDrug
Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline | Experimental | Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening Receives: Drug: Pentoxifylline+Tocopherol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure bone area (EBA)
exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA < 5 mm) at 12 months.
Measured: Month 12
Secondary outcomes (7)
SOMA score
describe the evolution of the modified SOMA score (pain, chewing, bone exposure size, trismus, radiological appearance)
Measured: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (albuminemia)
describe the nutritional parameters evolution albuminemia
Measured: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (pre-albuminemia)
describe the nutritional parameters evolution pre-albuminemia
Measured: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (weight)
describe the nutritional parameters evolution weight
Measured: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (BMI)
describe the nutritional parameters evolution BMI
Measured: Month 1, Month 3, Month 6, Month 12
Exposure bone area (EBA)
describe the evolution of the exposure bone area (EBA)
Measured: Month 1, Month 3, Month 6, Month 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
description of adverse events
Measured: Month 1, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start29 Feb 2024
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-related Osteonecrosis of the Jaw (MRONJ)Studies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie USSEGLIO, Dr, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795647
- Sponsor's protocol ID
- 87RI21_0052 (PENTO)
- Acronym
- PENTO
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PENTO Protocol in Medication-related Osteonecrosis of the Jaw
- ClinicalTrials.gov ID
- NCT05795647
- Acronym / sponsor ID
- PENTO / 87RI21_0052 (PENTO)
- Keywords
- MRONJ, pentoxifylline, tocophérol, bone exposure, renutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MRONJ is defined as intraoral bone exposure persisting for more than 8 weeks after taking an anti-resorptive agent (per os or IV bisphosphonates, targeted therapies) and without history of maxilla radiotherapy or metastasis. It leads to a significant decrease in quality of life with significant pain at rest and during mastication, and compromised nutrition, sometimes resulting in severe undernutrition in patients already weakened by a history of cancer. Current treatments (prolonged antibiotic therapy, repeated bone curettage) have shown partial effectiveness. PENTO (combination of pentoxifylline, a vasodilator, and tocopherol, vitamin E) has been shown to significantly reduce intraoral exposed bone surface area and pain in maxilla osteoradionecrosis. All studies conducted so far on PENTO in MRONJ are retrospective or involve small samples. Therefore, our idea is to perform a well-conducted prospective phase IIa study to prove the efficacy of PENTO, with a larger sample size and identical follow-up periods. The investigators will study patients with AAOMS stage 2 MRONJ (exposed bone in symptomatic patients, without pathologic fracture).
Treatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening. Antibiotic therapy with Augmentin (or clindamycin) will be added for the first month and then punctually if signs of local infection appear.
The primary and secondary endpoints will be assessed at inclusion and at 1, 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline | Experimental | Drug: Pentoxifylline+TocopherolTreatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- History of head or neck radiotherapy or maxilla metastases
- Patients who have received treatment in the past (PENTO or PENTOCLO protocol)
- Patients who have undergone surgery for their MRONJ within the last 3 months
- Pregnant or wishing to be pregnant, breastfeeding
- Patient under palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline+TocopherolTreatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening | Drug | Pentoxifylline |
Primary outcome
Exposure bone area (EBA)
Time frame: Month 12
exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA < 5 mm) at 12 months.
7 secondary outcomes
SOMA score
Time frame: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (albuminemia)
Time frame: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (pre-albuminemia)
Time frame: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (weight)
Time frame: Month 1, Month 3, Month 6, Month 12
Nutritional parameters evolution (BMI)
Time frame: Month 1, Month 3, Month 6, Month 12
Exposure bone area (EBA)
Time frame: Month 1, Month 3, Month 6, Month 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: Month 1, Month 3, Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Medication-related Osteonecrosis of the Jaw (MRONJ)
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Autologous Platelet Concentrates on the Healing of Extraction Sockets
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Recruiting
Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
Medication Related Osteonecrosis of the Jaw
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
Not yet recruitingObservational study
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
Not yet recruiting
L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0
Osteoradionecrosis of the Jaw, Medicine Related Osteonecrosis of the Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie USSEGLIO, Dr principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline+Tocopherol in people with Medication-related Osteonecrosis of the Jaw (MRONJ), run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie USSEGLIO, Dr (+33 (0) 555 056 120, julie.usseglio@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure bone area (EBA) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.