Trial Information
Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe
All women in the database meeting the inclusion criteria will be included in the study
without any statistical sampling.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Incidence of venous thromboembolism (VTE)
Outcome Time Frame:
During up to 5 years of follow up
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
European Union: European Medicines Agency
Study ID:
B1781044
NCT ID:
NCT01416194
Start Date:
July 2011
Completion Date:
August 2015
Related Keywords:
- Osteoporosis, Postmenopausal
- Osteoporosis
- Osteoporosis
- Osteoporosis, Postmenopausal
- Venous Thromboembolism