Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

Tracking Information
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; (submitted: August 11, 2011)	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; (submitted: July 13, 2013)	Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ]; Incidence of thrombotic cardiac disorders [ Time Frame: During up to 5 years of follow up ]; Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ]; Incidence of biliary events [ Time Frame: During up to 5 years of follow up ]; Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ]; Incidence of fracture [ Time Frame: During up to 5 years of follow up ]; Incidence of chronic renal failure [ Time Frame: During up to 5 years of follow up ]; Incidence of malignancies [ Time Frame: During up to 5 years of follow up ]; Incidence of depression [ Time Frame: During up to 5 years of follow up ]; Incidence of ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ]; Incidence of acute renal failure [ Time Frame: During up to 5 years of follow up ]; Selected ocular events including retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. [ Time Frame: During up to 5 years ]; Goiter [ Time Frame: During up to 5 years ]
Original Secondary Outcome Measures; (submitted: August 11, 2011)	Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ]; Incidence of thrombotic and ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ]; Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ]; Incidence of biliary events [ Time Frame: During up to 5 years of follow up ]; Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ]; Incidence of fracture [ Time Frame: During up to 5 years of follow up ]; Incidence of chronic and acute renal failure [ Time Frame: During up to 5 years of follow up ]; Incidence of malignancies [ Time Frame: During up to 5 years of follow up ]; Incidence of depression [ Time Frame: During up to 5 years of follow up ]
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
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	Drug: Bazedoxifene Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.; Drug: Bisphosphonate Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.; Drug: Raloxifene Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Study Groups/Cohorts	Bazedoxifene Intervention: Drug: Bazedoxifene; Primary Comparator Intervention: Drug: Bisphosphonate; Secondary Comparator Intervention: Drug: Raloxifene
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: March 30, 2018)	1
Original Estimated Enrollment; (submitted: August 11, 2011)	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: Female; At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);; A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;; Age >=45 at the date of the index prescription; and; At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription Exclusion Criteria: There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
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	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	March 2018