Trial · NCT01077817
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
NCT01077817, Completed, Organon and Co; results first posted 2013-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352). Trials, record NCT01077817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
- NCT number
- NCT01077817
- Status
- Completed
- Enrollment
- 684,815 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Esophageal Cancer, Squamous Cell Carcinoma, Adenocarcinoma
- Interventions
- Alendronate, Etidronate, Ibandronate, Risedronate, Raloxifene
- First posted
- 2010-03-01
- Last updated
- 2022-02-03
- Results first posted
- 2013-05-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | 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. |
| Primary | Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Exposure to study drug at least 720 days before disease onset | 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 | NUMBER |
| PRIMARY | Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis) | Up to approximately 7.3 years of follow-up | 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. | Number of cases per 100,0000 woman-years | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Esophageal Cancer Cohort | Alendronate | 4.6 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Comparison Sample (Case Cohort) | Alendronate | 2.7 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Esophageal Cancer Cohort | Etidronate | 3.7 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Comparison Sample (Case Cohort) | Etidronate | 2.1 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Esophageal Cancer Cohort | Ibandronate | 0.3 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Comparison Sample (Case Cohort) | Ibandronate | 0.03 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Esophageal Cancer Cohort | Risedronate | 2.6 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Comparison Sample (Case Cohort) | Risedronate | 0.9 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Esophageal Cancer Cohort | Raloxifene | 0.3 | Percentage of participants | |
| Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) | Comparison Sample (Case Cohort) | Raloxifene | 0.4 | Percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study Population | 684,815 | |
| Overall Study | COMPLETED | Overall Study Population | 684,815 | |
| Overall Study | NOT COMPLETED | Overall Study Population | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study Population | ||
| Total, other adverse events | Overall Study Population | 0 | 0 |
| Total, serious adverse events | Overall Study Population | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01077817
GET https://conductscience.org/api/trials/v1/NCT01077817/registered