International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns of Patients With Medication-related Osteonecrosis of the Jaw (MRONJ) and Their Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 518
- 试验地点
- 14
- 主要终点
- Treatment outcome
研究概览
简要总结
Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.
详细描述
Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or
- •Newly diagnosed patients with non-exposed MRONJ (stage 0), or
- •Newly diagnosed patients with exposed MRONJ, i.e:
- •Current or previous treatment with antiresorptive or antiangiogenic agents.
- •Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks
- •No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw
- •Ability to understand the content of the patient information/ Informed Consent Form
- •Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
- •Signed and dated IRB/EC-approved written informed consent
- •Mental capacity to comply with post-operative regimen, evaluation and data collection
排除标准
- •Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the registry period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
结局指标
主要结局
Treatment outcome
时间窗: 6 months / 1 year
Compared to the baseline status of the patient's condition, the outcome will be evaluated as: * Worsening of the osteonecrosis (e.g. size of the lesion increased) * No change of the osteonecrosis * Reduction of the osteonecrosis (e.g. size of the lesion decrease) * Complete mucosa healing
次要结局
- Pain perception(6 months / 1 year)
- Staging of osteonecrosis(6 months / 1 year)
- Site and size of the lesion(6 months / 1 year)