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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

684815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-26

Study Completion Date

2012-02-16

Brief Summary

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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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Detailed Description

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Conditions

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Esophageal Cancer Squamous Cell Carcinoma Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Alendronate

Intervention Type DRUG

Etidronate

Intervention Type DRUG

Ibandronate

Intervention Type DRUG

Risedronate

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

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.

Alendronate

Intervention Type DRUG

Etidronate

Intervention Type DRUG

Ibandronate

Intervention Type DRUG

Risedronate

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Non-treated Comparators

Participants who did not initiate treatment of osteoporosis with a study drug

No interventions assigned to this group

Alendronate

Participants initiating treatment for osteoporosis with alendronate

Alendronate

Intervention Type DRUG

Etidronate

Participants initiating treatment for osteoporosis with etidronate

Etidronate

Intervention Type DRUG

Ibandronate

Participants initiating treatment for osteoporosis with ibandronate

Ibandronate

Intervention Type DRUG

Risedronate

Participants initiating treatment for osteoporosis with risedronate

Risedronate

Intervention Type DRUG

Raloxifene

Participants initiating treatment for osteoporosis with raloxifene

Raloxifene

Intervention Type DRUG

Interventions

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Alendronate

Intervention Type DRUG

Etidronate

Intervention Type DRUG

Ibandronate

Intervention Type DRUG

Risedronate

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Other Intervention Names

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FOSAMAX® DIDRONEL® BONIVA® ACTONEL® ATELVIA® EVISTA®

Eligibility Criteria

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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.