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Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe


Phase 4
45 Years
N/A
Open (Enrolling by invite only)
Female
Osteoporosis, Postmenopausal

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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

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