Trials / Completed
CompletedNCT01416194
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,497 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-07-25
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
- First posted
- 2011-08-12
- Last updated
- 2024-04-22
- Results posted
- 2020-05-18
Source: ClinicalTrials.gov record NCT01416194. Inclusion in this directory is not an endorsement.