NCT01967160已完成不适用
A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2,560
- 主要终点
- 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
研究概览
简要总结
A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •diagnosed with cancer
- •subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)
排除标准
- •history of radiation treatment for head and neck cancer before a subject's potential index date
- •hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent
结局指标
主要结局
2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
时间窗: 3 years
1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
时间窗: 5 years
次要结局
- 1. Incidence proportions of medically confirmed ONJ in the cohort switching from an oral or IV bisphosphonate (at the dose indicated for cancer patients to prevent skeletal related events) to XGEVA(5 years)
- 2. Incidence proportions of medically confirmed ONJ in the cohort switching from an oral or IV bisphosphonate (at the dose indicated for cancer patients to prevent SREs) to XGEVA stratified by number of prior cancer-related bisphosphonate treatments(5 years)
- 3. Characterize the XGEVA inception, zoledronic acid inception, and the XGEVA-switch cohorts with respect to patient characteristics, cancer type, medical history, and number of bisphosphonate or XGEVA treatments at the dose indicated for SRE prevention(5 years)
- 4. Summarize oral risk factor information for medically confirmed ONJ cases(5 years)
- 5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution(5 years)
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