Medication-related osteonecrosis of the jaw (MRONJ) MedDRA version: 23.1 Level: LLT Classification code 10084881 Term: Medication-related osteonecrosis of jaw System Organ Class: 100000004859
Conditions
Interventions
Trade Name: PENTOXIFYLLINE
Pharmaceutical Form: Tablet
INN or Proposed INN: Pentoxifylline
CAS Number: 6493-05-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400
Sponsors
Limoges University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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, contraception is required (excluding periodic abstinence, withdrawal, lactational amenorrhea, spermicide alone) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - 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 - History of hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactams (or dalacin if applicable) - History of jaundice/hepatic injury related to amoxicillin/clavulanic acid - Patient taking oral anticoagulants, or with a history of major bleeding or bleeding disorders - Patients with a history of hepatic failure, renal failure (Cl < 30 mL/min), hypotension (SBP (systolic blood pressure) < 90 mmHg) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the proportion of healing (defined as an area of bone exposure (ABE) < 5 mm) in patients receiving PENTO in osteochimionecrosis at 12 months;Secondary Objective: The secondary objectives are : - to describe the evolution of the modified SOMA score - to describe the nutritional parameters evolution, - to follow the EBA evolution, - to evaluate the treatment tolerance (description of adverse events) at 12 months. ;Primary end point(s): The primary endpoint is healing as defined by an 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;Timepoint(s) of evaluation of this end point: 12 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The evolution of the modified SOMA score (qualitative and quantitative items) over 12 months: 0 -> 26 : Subjective: - Pain (occasional/minimal, intermittent/tolerate, persistent/intense, refractory) - Chewing (difficult with solids, with soft food, gastrostomy) Objective: - Bone exposure (minimal ulceration, 4 cm/fracture) - Trismus (minimal, 1-2 cm mouth opening, 0.5-1 cm, < 0.5cm) Management: - Pain (occasional, regular non-morphine treatment, regular morphine treatment, surgery) - Bone exposure (mouthwash, antibiotic therapy, debridement/HBO) Analytic: - Mandibular radiography (doubts, heterogeneous, sequestration, fracture) • Evolution of nutritional parameters over 12 months: - Patient's weight and BMI - Albuminemia in g/L (nomes 35-50 g/L) - Pre-albuminemia in mg/L (norms 250-350 mg/L) • Dimension and evolution of ABE (clinical) over 12 months: - Quantitative assessment: D dimension = major axis measurement of mucosal loss - Evolution: Relative regression D (= (D at x months - D at inclusion)/D at inclusion) • Collection of adverse events over 12 months, according to their nature, severity, severity (mild, moderate, severe) and causality;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
France
Contacts
Public ContactLoïc MARAIS
Limoges University Hospital
Outcome results
None listed