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

Organon

Status: Completed

Conditions: Squamous Cell Carcinoma; Esophageal Cancer; Adenocarcinoma

Treatments: Drug: Etidronate; Drug: Ibandronate; Drug: Alendronate; Drug: Risedronate; Drug: Raloxifene

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01077817

2010_015 (Other Identifier)

EP02001.029 (Other Identifier)

0217A-352

Details and patient eligibility

About

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.

Enrollment: 684,815 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

684,815 participants in 8 patient groups

Esophageal Cancer Cases

Description:

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.

Treatment:

Drug: Raloxifene

Drug: Risedronate

Drug: Alendronate

Drug: Ibandronate

Drug: Etidronate

Comparison Sample (Case-Cohort)

Description:

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.

Treatment:

Drug: Raloxifene

Drug: Risedronate

Drug: Alendronate

Drug: Ibandronate

Drug: Etidronate

Non-treated Comparators

Description:

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

Alendronate

Description:

Participants initiating treatment for osteoporosis with alendronate

Treatment:

Drug: Alendronate

Etidronate

Description:

Participants initiating treatment for osteoporosis with etidronate

Treatment:

Drug: Etidronate

Ibandronate

Description:

Participants initiating treatment for osteoporosis with ibandronate

Treatment:

Drug: Ibandronate

Risedronate

Description:

Participants initiating treatment for osteoporosis with risedronate

Treatment:

Drug: Risedronate

Raloxifene

Description:

Participants initiating treatment for osteoporosis with raloxifene

Treatment:

Drug: Raloxifene