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Completed

NCT Number: NCT01077817

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

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.

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Key information

Conditions

Esophageal Cancer Adenocarcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate

Drug

Other names: FOSAMAX®

Etidronate

Drug

Other names: DIDRONEL®

Ibandronate

Drug

Other names: BONIVA®

risedronate

Drug

Other names: ACTONEL®, ATELVIA®

Raloxifene

Drug

Other names: EVISTA®

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • World Health Information Science Consultants, LLC

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2010
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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