跳至主要内容
临床试验/NCT01967160
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

Amgen0 个研究点目标入组 2,560 人开始时间: 2012年1月2日最近更新:
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

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)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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