Osteonecrosis of the Jaw (ONJ) Case Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Resolution rate and time to ONJ resolution
研究概览
简要总结
Osteonecrosis of the Jaw (ONJ) Case Registry
详细描述
The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.
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
- •Adult (≥18 years of age) with diagnosis of cancer
- •Newly diagnosed, positively-adjudicated ONJ
- •ECOG <=2 and expected survival ≥3 months
- •Willing to provide access to previous and future medical and dental information
- •Subject or subject's legally acceptable representative has provided written informed consent
排除标准
- •History of radiation to the jaws administered for the treatment of cancer
- •Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
- •Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
结局指标
主要结局
Resolution rate and time to ONJ resolution
时间窗: 5 years
* Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms * Improvement: a decrease in the stage or severity of the lesion * Progression: an increase in the stage or severity of the lesion * Stable: not resolved, improved, or progressed
次要结局
- The clinical features of ONJ, including severity and staging at enrollment(5 years)
- The frequency of risk factors for incident ONJ(5 years)
- Therapeutic treatment patterns for ONJ(5 years)
- Treatment patterns of antiresorptive agents subsequent to incident ONJ(5 years)