Neoplasms

All Conditions

Digestive System Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Adenocarcinoma

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Bone Density Conservation Agents

All Drugs and Chemicals

Channel Blockers

Etidronic Acid

Alendronate

Raloxifene Hydrochloride

Ibandronic Acid

Risedronic Acid

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

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.

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.

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

Participants initiating treatment for osteoporosis with alendronate

Participants initiating treatment for osteoporosis with etidronate

Participants initiating treatment for osteoporosis with ibandronate

Participants initiating treatment for osteoporosis with risedronate

Participants initiating treatment for osteoporosis with raloxifene

Etidronate

Ibandronate

Risedronate

Raloxifene

Alec Walker, MD, DrPH

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.

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

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

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.

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.

World Health Information Science Consultants, LLC

Organon and Co

Adverse events were not collected during this study.

Overall Study Population

≥55

Age, Customized

Sex: Female, Male

Senior Vice President, Global Clinical Development

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.

Participants with any GPRD Medical Code for esophageal cancer (cases).

Esophageal Cancer Cohort

Comparison Sample (Case Cohort)

Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.

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

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate

compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate

compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate

compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate

compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene

compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only

esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,

only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,

only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only

esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate

compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate

compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate

compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene

compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

Participants who did not initiate osteoporosis treatment with a study drug

Comparators

Participants who initiated osteoporosis treatment with alendronate

Participants who initiated osteoporosis treatment with etidronate

Participants who initiated osteoporosis treatment with ibandronate

Participants who initiated osteoporosis treatment with risedronate

Risendronate

Participants who initiated osteoporosis treatment with raloxifene

Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.

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

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