Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01077817
Collaborator
World Health Information Science Consultants, LLC (Other)
684,815
23.7
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
684815 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women
Actual Study Start Date
:
Feb 26, 2010
Actual Primary Completion Date
:
Feb 16, 2012
Actual Study Completion Date
:
Feb 16, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Alendronate
Other Names:
Drug: Etidronate
Other Names:
Drug: Ibandronate
Other Names:
Drug: Risedronate
Other Names:
Drug: Raloxifene
Other Names:
|
| 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. |
Drug: Alendronate
Other Names:
Drug: Etidronate
Other Names:
Drug: Ibandronate
Other Names:
Drug: Risedronate
Other Names:
Drug: Raloxifene
Other Names:
|
| Non-treated Comparators Participants who did not initiate treatment of osteoporosis with a study drug |
|
| Alendronate Participants initiating treatment for osteoporosis with alendronate |
Drug: Alendronate
Other Names:
|
| Etidronate Participants initiating treatment for osteoporosis with etidronate |
Drug: Etidronate
Other Names:
|
| Ibandronate Participants initiating treatment for osteoporosis with ibandronate |
Drug: Ibandronate
Other Names:
|
| Risedronate Participants initiating treatment for osteoporosis with risedronate |
Drug: Risedronate
Other Names:
|
| Raloxifene Participants initiating treatment for osteoporosis with raloxifene |
Drug: Raloxifene
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
- World Health Information Science Consultants, LLC
Investigators
- Study Director: Alec Walker, MD, DrPH, World Health Information Science Consultants, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT01077817
Other Study ID Numbers:
- 0217A-352
- EP02001.029
- 2010_015
First Posted:
Mar 1, 2010
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were not recruited nor enrolled in this study. This study is a retrospective observational study. Data from the GPRD were anonymized and used to develop participant cohorts. All diagnoses and treatments were recorded in the course of routine medical practice. |
|---|---|
| Pre-assignment Detail | 684,815 women in the General Practice Research Database (GPRD) formed the Overall Study Population. These women met the demographic criteria of being age 55 or older, were born between 1922 and 1955, had more than 720 days experience in the GPRD and at least one of those days fell between 1996 and 2008. |
| Arm/Group Title | Overall Study Population |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 684815 |
| COMPLETED | 684815 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Overall Study Population |
|---|---|
| Arm/Group Description | |
| Overall Participants | 684815 |
| Age, Customized (Number) [Number] | |
| <55 |
0
0%
|
| ≥55 |
684815
100%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
684815
100%
|
| Male |
0
0%
|
Outcome Measures
| Title | Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis) |
|---|---|
| Description | 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. |
| Time Frame | Exposure to study drug at least 720 days before disease onset |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Esophageal Cancer Cohort | Comparison Sample (Case Cohort) |
|---|---|---|
| Arm/Group Description | Participants with any GPRD Medical Code for esophageal cancer (cases). | 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. |
| Measure Participants | 929 | 338911 |
| Alendronate |
4.6
0%
|
2.7
NaN
|
| Etidronate |
3.7
0%
|
2.1
NaN
|
| Ibandronate |
0.3
0%
|
0.03
NaN
|
| Risedronate |
2.6
0%
|
0.9
NaN
|
| Raloxifene |
0.3
0%
|
0.4
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 4.9 | |
| Confidence Interval |
(2-Sided) 95% 1.4 to 16.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.6 | |
| Confidence Interval |
(2-Sided) 95% 1.0 to 2.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% 0.2 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis) |
|---|---|
| Description | 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. |
| Time Frame | Up to approximately 7.3 years of follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Comparators | Alendronate | Etidronate | Ibandronate | Risendronate | Raloxifene |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who did not initiate osteoporosis treatment with a study drug | 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 | Participants who initiated osteoporosis treatment with raloxifene |
| Measure Participants | 300610 | 48377 | 7851 | 3941 | 15655 | 2806 |
| Number [Number of cases per 100,0000 woman-years] |
32
|
32
|
42
|
46
|
47
|
29
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Etidronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% 0.8 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Ibandronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Risendronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Raloxifene |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 2.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Etidronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.2 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Ibandronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 3.0 | |
| Confidence Interval |
(2-Sided) 95% 0.8 to 11.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Risendronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.8 | |
| Confidence Interval |
(2-Sided) 95% 1.1 to 3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Raloxifene |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.1 to 2.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Comparison Sample (Case Cohort) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 1.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Etidronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Risendronate |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 2.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Esophageal Cancer Cohort, Raloxifene |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.2 to 3.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | Adverse events were not collected during this study. | |
| Arm/Group Title | Overall Study Population | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT01077817
Other Study ID Numbers:
- 0217A-352
- EP02001.029
- 2010_015
First Posted:
Mar 1, 2010
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022