Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ): A Prospective, Randomized Controlled Trial to Evaluate a Novel Non-operative Treatment
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in Bone exposure area (mm^2)
研究概览
简要总结
The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?
详细描述
HYPOTHESES
HA: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will be different than the area of exposed bone in the standard therapy group.
H0: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will equal the area of exposed bone in the standard therapy group.
SPECIFIC AIMS
To determine if the PENTO regimen in addition to the standard of care treatment for MRONJ significantly reduces the area of exposed bone compared to standard of care alone. Standard of care is defined as the clinical guidelines of the 2014 AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw (MRONJ)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014).
- •History of exposure to antiresorptive medications such as bisphosphonates or RANK-L inhibitors
- •Absence of tumor in the jaw at the time of recruitment
- •Patients with the capacity to give informed consent
排除标准
- •Patients with history of external radiation therapy to the jaws
- •Patients who underwent any surgical intervention for MRONJ in the past 4 months
- •Patients with past microvascular reconstruction of the head and neck
- •Patients with an expected survival less than 1 year
- •Patients with allergy or hypersensitivity to pentoxifylline, xanthines, or tocopherol
- •Patients with planned invasive dental procedure in the next year
- •Patients taking oral anticoagulants
- •Patients with known hemorrhagic and coagulation disorder
- •Patients with a vitamin K deficiency due to any cause
- •Female patients who are pregnant or lactating
- •Patients with history of serious bleeding or extensive retinal hemorrhage
- •Patients with ischemic heart diseases, including, but not limiting, recent myocardial infarction
- •Patients with serious cardiac arrhythmia
- •Patients with severe liver disease
- •Patients with severe renal failure (Creatinine clearance <30 mL/min)
- •Patients with diagnosed hypotension
- •Patients taking CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine)
- •Diagnosis of MRONJ with no exposed bone
- •Patient cannot tolerate impressions of exposed bone in a clinical setting, if needed.
- •There is a change in the patient's clinical presentation (tooth extraction, sequestrectomy) from alginate impression, if impression is indicated.
- •Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- •Patients who are taking additional vitamin E, or you will confirm they will stop taking vitamin E if they decide to enroll in this study.
- •Patients who are taking oral anticoagulant medications.
- •Discuss with patients taking aspirin and other supplements/medications that impact coagulation to determine if the study is a good fit, and will exclude an individual whose situation or condition may interfere with safe participation in the study.
研究组 & 干预措施
Standard of Care + PENTO
The current standard of care for MRONJ as outlined by the American Association of Oral and Maxillofacial Surgeons position paper based on stage of disease (Ruggiero 2014) AND PENTO regimen consisting of 400mg pentoxifylline (PTX) and 400IU tocopherol twice-daily PO for a total of 800mg/day PTX and 800 IU/day tocopherol
干预措施: Pentoxifylline (Drug)
Standard of Care + PENTO
The current standard of care for MRONJ as outlined by the American Association of Oral and Maxillofacial Surgeons position paper based on stage of disease (Ruggiero 2014) AND PENTO regimen consisting of 400mg pentoxifylline (PTX) and 400IU tocopherol twice-daily PO for a total of 800mg/day PTX and 800 IU/day tocopherol
干预措施: Tocopherol (Drug)
Standard of Care
The current standard of care for MRONJ as outlined by the American Association of Oral and Maxillofacial Surgeons position paper based on stage of disease (Ruggiero 2014). Placebo drugs to be taken in the control group 2 pills BID.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Bone exposure area (mm^2)
时间窗: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
The primary lesion's area of exposed bone will be estimated by measuring the greatest anterior-posterior and superior-inferior dimensions in millimeters (mm) of the site with the largest area of exposed bone present at the time of study enrollment. If there are multiple areas of exposed bone in a single patient, the site with the largest sum of linear anterior-posterior and superior-inferior dimensions will be included in the study.
次要结局
- Change in osseous anterior-posterior linear dimension on orthopantomogram(0 months, 1 month, 3 months, 6 months, 9 months, 12 months)
- Change in MRONJ Stage(0 months, 1 month, 3 months, 6 months, 9 months, 12 months)
- Change in Pain(0 months, 1 month, 3 months, 6 months, 9 months, 12 months)
- Change in osseous superior-inferior linear dimension on orthopantomogram(0 months, 1 month, 3 months, 6 months, 9 months, 12 months)
- Change in osseous area on orthopantomogram(0 months, 1 month, 3 months, 6 months, 9 months, 12 months)
研究者
Jasjit Dillon
Professor & Chief, Program Director, Oral & Maxillofacial Surgery
University of Washington