The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women (MK-0217A-352)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALENDRONATE SODIUM

  ETIDRONATE DISODIUM

  RALOXIFENE

  RISEDRONATE SODIUM

  SODIUM IBANDRONATE
• Medical condition to be studied:
  Gastrooesophageal cancer

  Squamous cell carcinoma

  Adenocarcinoma

Population studied

• Short description of the study population:
  Women born between 1922 and 1953 with records in the GPRD between 1996 and 2008 who begins treatment for osteoporosis.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  684815

Study design details

• Main study objective:
  To quantify the relation between prescription of agents used in the treatment of osteoporosis and the subsequent occurrence of esophageal cancer.
• Outcomes:
  1. Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) 2.Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
• Data analysis plan:
  In the case-cohort study, the effects of covariates and drug exposures were evaluated through a logistic regression model with conditioning on the matched set consisting of the case and her controls. In the intent-to-treat analysis, a proportional hazards regression model was used, with stratification on year of birth, calendar quarter of cohort entry, and exposure history. Both analyses used a robust variance estimator to account for the participation of individuals in multiple matched sets or strata.