Clinical trial NCT01416194: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Keywords: Osteoporosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 10497
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Cumulative Incidence of Venous Thromboembolism (VTE)
timeFrame: Up to a maximum of follow-up period of 92.1 months
Secondary outcomes:
measure: Cumulative Incidence of Ischemic Stroke
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Cardiac Disorders
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Atrial Fibrillation
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Biliary Events
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Hypertriglyceridemia
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Clinical Fractures
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Renal Failure
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of All Malignancies
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Different Types of Malignancies
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Depression
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Selected Ocular Events
timeFrame: Up to a maximum of follow-up period of 92.1 months
measure: Cumulative Incidence of Thyroid Disorders- Goitre
timeFrame: Up to a maximum of follow-up period of 92.1 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: