2024-518688-36-00招募中2 期
The PENTO protocol in Medication-Related Osteonecrosis of the Jaw (MRONJ): a single-center phase IIa trial
Centre Hospitalier Et Universitaire De Limoges1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年10月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The primary objective is to assess the proportion of healing (defined as a bone exposure area (EBA) < 5 mm) in patients receiving PENTO for osteochimionecrosis at 12 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of head or neck radiotherapy or maxilla metastases
- •(secondary exclusion criteria) patient who sign a consent and present at inclusion a finding of hepatic, renal failure (Cl < 30 mL/min), thrombocytopenia (Pl < 80 G/L) or arterial hypotension (SAP < 90 mmHg).
- •(secondary exclusion criteria) patient who sign a consent and present at inclusion a positive beta-HCG assay (≥ 5 IU/L)
- •Patient taking platelet aggregation inhibitor, theophylline or aminophylline
- •(secondary exclusion criteria) patient who sign a consent and present at inclusion an exposure bone area (EBA) less than 5 mm (EBA<5mm)
- •(secondary exclusion criteria) patient who sign a consent and is not receiving study treatment
- •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
- •Patients who have received treatment in the last 3 months (PENTO or PENTOCLO protocol)
- •Patient unable to understand the protocol
- •Patient under curatorship or guardianship
- •Patient with recent or acute infarction
- •Patient taking ciprofloxacin
- •Patient taking oral antidiabetics or insulin
- •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 other methylxantine derivative or tocopherol or to an excipient
- •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
结局指标
主要结局
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.
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.
次要结局
- Progression of the modified SOMA score over 12 months: The modified SOMA score will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months.
- Progression of nutritional parameters over 12 months: These parameters are weight (in kg), BMI (in kg/m²), albuminemia (g/L) and pre-albuminemia (mg/L). These parameters will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months.
- 12-month change in EBA (dimension): This endpoint will be assessed quantitatively by the D dimension of EBA, defined as the measurement of the major axis of mucosal loss. This parameter will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months. The evolution of EBA corresponds to the relative regression of D defined by (D at x months - D at inclusion)/D at inclusion.
- All adverse events are collected via questioning and blood pressure measurement at each follow-up visit (at 1-3-6-12 months). Data collected on adverse events will cover their nature, severity (mild, moderate, severe) and causality.
研究者
coordinating investigator
Scientific
Centre Hospitalier Et Universitaire De Limoges
研究点 (1)
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