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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01416194

First received: August 11, 2011

Last updated: September 12, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2011

Last Updated Date

September 12, 2016

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

April 2019 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of venous thromboembolism (VTE) [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01416194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of thrombotic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of chronic renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Goiter [ Time Frame: During up to 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of thrombotic and ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of chronic and acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Osteoporosis, Postmenopausal

Intervention ^ICMJE

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 Group/Cohort (s)

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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2019

Estimated Primary Completion Date

April 2019 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Not Provided

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01416194

Other Study ID Numbers ^ICMJE

B1781044

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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