Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077817
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : May 1, 2013
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
World Health Information Science Consultants, LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Esophageal Cancer Squamous Cell Carcinoma Adenocarcinoma Drug: Alendronate Drug: Etidronate Drug: Ibandronate Drug: Risedronate Drug: Raloxifene

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 684815 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women
Actual Study Start Date : February 26, 2010
Actual Primary Completion Date : February 16, 2012
Actual Study Completion Date : February 16, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: FOSAMAX®

Drug: Etidronate
Other Name: DIDRONEL®

Drug: Ibandronate
Other Name: BONIVA®

Drug: Risedronate
Other Names:
  • ACTONEL®
  • ATELVIA®

Drug: Raloxifene
Other Name: EVISTA®
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 Name: FOSAMAX®

Drug: Etidronate
Other Name: DIDRONEL®

Drug: Ibandronate
Other Name: BONIVA®

Drug: Risedronate
Other Names:
  • ACTONEL®
  • ATELVIA®

Drug: Raloxifene
Other Name: EVISTA®
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 Name: FOSAMAX®
Etidronate
Participants initiating treatment for osteoporosis with etidronate
 Drug: Etidronate
Other Name: DIDRONEL®
Ibandronate
Participants initiating treatment for osteoporosis with ibandronate
 Drug: Ibandronate
Other Name: 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 Name: EVISTA®


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077817


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
World Health Information Science Consultants, LLC
Investigators
Layout table for investigator information
Study Director: Alec Walker, MD, DrPH World Health Information Science Consultants, LLC
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077817    
Other Study ID Numbers: 0217A-352
EP02001.029 ( Other Identifier: Merck )
2010_015 ( Other Identifier: Merck )
First Posted: March 1, 2010    Key Record Dates
Results First Posted: May 1, 2013
Last Update Posted: July 11, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Osteoporosis
Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Alendronate
 Risedronic Acid
Ibandronic Acid
Raloxifene Hydrochloride
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators