Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01416194 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 12, 2011
Last Update Posted
: April 3, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
Tracking Information | ||||
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First Submitted Date | August 11, 2011 | |||
First Posted Date | August 12, 2011 | |||
Last Update Posted Date | April 3, 2018 | |||
Actual Study Start Date | July 2011 | |||
Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Incidence of venous thromboembolism (VTE) [ Time Frame: During up to 5 years of follow up ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01416194 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU) | |||
Official Title | Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe | |||
Brief Summary | This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups. | |||
Detailed Description | All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain. | |||
Condition | Osteoporosis, Postmenopausal | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Actual Enrollment |
1 | |||
Original Estimated Enrollment |
10750 | |||
Estimated Study Completion Date | April 2019 | |||
Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Not Provided | |||
Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01416194 | |||
Other Study ID Numbers | B1781044 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | March 2018 |