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

February 1, 2022 updated by: Organon and Co

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

684815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who have at least two years of experience in the GPRD and are 55 or older between 1996 and 2008; all cases of esophageal cancer were identified and matched to all women in the comparison sample (all women with same year of birth drawn from the random subsample of 25,000).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Alendronate
Other Names:
  • FOSAMAX®
Drug: Raloxifene
Other Names:
  • EVISTA®
Drug: Etidronate
Other Names:
  • DIDRONEL®
Drug: Ibandronate
Other Names:
  • BONIVA®
Drug: Risedronate
Other Names:
  • ACTONEL®
  • ATELVIA®
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.
Drug: Alendronate
Other Names:
  • FOSAMAX®
Drug: Raloxifene
Other Names:
  • EVISTA®
Drug: Etidronate
Other Names:
  • DIDRONEL®
Drug: Ibandronate
Other Names:
  • BONIVA®
Drug: Risedronate
Other Names:
  • ACTONEL®
  • ATELVIA®
Non-treated Comparators
Participants who did not initiate treatment of osteoporosis with a study drug
Alendronate
Participants initiating treatment for osteoporosis with alendronate
Drug: Alendronate
Other Names:
  • FOSAMAX®
Etidronate
Participants initiating treatment for osteoporosis with etidronate
Drug: Etidronate
Other Names:
  • DIDRONEL®
Ibandronate
Participants initiating treatment for osteoporosis with ibandronate
Drug: Ibandronate
Other Names:
  • BONIVA®
Risedronate
Participants initiating treatment for osteoporosis with risedronate
Drug: Risedronate
Other Names:
  • ACTONEL®
  • ATELVIA®
Raloxifene
Participants initiating treatment for osteoporosis with raloxifene
Drug: Raloxifene
Other Names:
  • EVISTA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
Time Frame: 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.
Exposure to study drug at least 720 days before disease onset
Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
Time Frame: 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.
Up to approximately 7.3 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

World Health Information Science Consultants, LLC

Investigators

  • Study Director: Alec Walker, MD, DrPH, World Health Information Science Consultants, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2010

Primary Completion (Actual)

February 16, 2012

Study Completion (Actual)

February 16, 2012

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0217A-352
  • EP02001.029 (Other Identifier: Merck)
  • 2010_015 (Other Identifier: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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