DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer; Squamous Cell Carcinoma; Adenocarcinoma

Intervention: Alendronate (Drug); Etidronate (Drug); Ibandronate (Drug); Risedronate (Drug); Raloxifene (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Alec Walker, MD, DrPH, Study Director, Affiliation: World Health Information Science Consultants, LLC


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.

Clinical Details

Official title: The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)

Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)


Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.


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

Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: April 27, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017