N/A
N=684,815
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
Esophageal Cancer · Squamous Cell Carcinoma · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01077817 ↗Enrolled (actual)
684,815
Serious AEs
—
Results posted
May 2013
Primary outcome: Primary: Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) — 4.6; 2.7; 3.7; 2.1 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Alendronate (Drug); Etidronate (Drug); Ibandronate (Drug); Risedronate (Drug); Raloxifene (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) |
4.6; 2.7; 3.7; 2.1; 0.3; 0.03 | — |
| PRIMARY Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis) |
32; 32; 42; 46; 47; 29 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01077817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.