The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 684,815
- 主要终点
- Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
研究概览
简要总结
This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in the database aged 55 or older between 1996 and 2008 with diagnosis of esophageal cancer
- •Comparator Controls:
- •Each case was matched to all women in the random subcohort of 25,000 who had the same year of birth as the case and were in the database at the time of diagnosis.
排除标准
- •Women with diagnosis of any other cancer or Paget's Disease or who have received oral or intravenous steroids before the index date
研究组 & 干预措施
Esophageal Cancer Cases
Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
干预措施: Alendronate (Drug)
Esophageal Cancer Cases
Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
干预措施: Etidronate (Drug)
Esophageal Cancer Cases
Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
干预措施: Ibandronate (Drug)
Esophageal Cancer Cases
Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
干预措施: Risedronate (Drug)
Esophageal Cancer Cases
Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
干预措施: Raloxifene (Drug)
Comparison Sample (Case-Cohort)
Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
干预措施: Alendronate (Drug)
Comparison Sample (Case-Cohort)
Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
干预措施: Etidronate (Drug)
Comparison Sample (Case-Cohort)
Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
干预措施: Ibandronate (Drug)
Comparison Sample (Case-Cohort)
Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
干预措施: Risedronate (Drug)
Comparison Sample (Case-Cohort)
Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
干预措施: Raloxifene (Drug)
Alendronate
Participants initiating treatment for osteoporosis with alendronate
干预措施: Alendronate (Drug)
Etidronate
Participants initiating treatment for osteoporosis with etidronate
干预措施: Etidronate (Drug)
Ibandronate
Participants initiating treatment for osteoporosis with ibandronate
干预措施: Ibandronate (Drug)
Risedronate
Participants initiating treatment for osteoporosis with risedronate
干预措施: Risedronate (Drug)
Raloxifene
Participants initiating treatment for osteoporosis with raloxifene
干预措施: Raloxifene (Drug)
结局指标
主要结局
Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
时间窗: Exposure to study drug at least 720 days before disease onset
To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.
Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
时间窗: Up to approximately 7.3 years of follow-up
To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.
次要结局
未报告次要终点