NCT00874211已完成不适用
S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastases Starting Zoledronic Acid Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,571
- 试验地点
- 451
- 主要终点
- Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
研究概览
简要总结
RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care.
PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.
详细描述
OBJECTIVES:
Primary
- To prospectively access the cumulative incidence of osteonecrosis of the jaw (ONJ) at 3 years in cancer patients with bone metastasis receiving zoledronic acid treatment.
Secondary
- To describe the clinical presentation and natural history of ONJ.
- To identify potential risk factors for the development of ONJ.
- To estimate the cumulative incidence of ONJ at 3 years for different tumor types (i.e., breast cancer, multiple myeloma, prostate cancer, lung cancer, and other cancers).
- To better define the patient-related outcomes of ONJ.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
时间窗: 3 years
次要结局
- Clinical presentation and natural history of ONJ(3 years)
- Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ(3 years)
- Association between patient-related outcomes and confirmed incidence(3 years)
- Overall and disease-specific cumulative incidence(3 years)
- Association of baseline factors with cumulative incidence of confirmed ONJ(3 years)
研究者
研究点 (451)
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