Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)

• Status: Completed
• Trial end date: 2012-02-16
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: World Health Information Science Consultants, LLC
• Treatments: Alendronate; Diphosphonates; Etidronic Acid; Ibandronic Acid; Raloxifene Hydrochloride; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• Cases:

• 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.

Exclusion Criteria:

• Women with diagnosis of any other cancer or Paget's Disease or who have received oral or intravenous steroids before the index date