N/A
Completed N=10,497
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT01416194 ↗
Enrolled (actual)
10,497
Serious AEs
—
Results posted
May 2020
Primary outcomePrimary: Cumulative Incidence of Venous Thromboembolism (VTE) — 1.5; 2.2; 4.6 percentage of participants — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Venous Thromboembolism (VTE) |
1.5; 2.2; 4.6 | <0.01 sig |
| SECONDARY Cumulative Incidence of Ischemic Stroke |
2.2; 2.6; 6.7 | <0.01 sig |
| SECONDARY Cumulative Incidence of Cardiac Disorders |
2; 3; 6.6 | 0.01 sig |
| SECONDARY Cumulative Incidence of Atrial Fibrillation |
2.8; 4.3; 6.5 | 0.10 |
| SECONDARY Cumulative Incidence of Biliary Events |
1.8; 2; 4 | <0.01 sig |
| SECONDARY Cumulative Incidence of Hypertriglyceridemia |
9.7; 10.6; 6 | <0.01 sig |
| SECONDARY Cumulative Incidence of Clinical Fractures |
4.4; 8.2; 12.8 | <0.01 sig |
| SECONDARY Cumulative Incidence of Renal Failure |
0.8; 2.3; 4.8 | <0.01 sig |
| SECONDARY Cumulative Incidence of All Malignancies |
3.2; 4.4; 6.6 | <0.01 sig |
| SECONDARY Cumulative Incidence of Different Types of Malignancies |
0.1; 0.2; 0.4; 0.6; 1.4; 0.1 | — |
| SECONDARY Cumulative Incidence of Depression |
10.1; 9.2; 8.6 | 0.24 |
| SECONDARY Cumulative Incidence of Selected Ocular Events |
8; 12.5; 10.8 | 0.03 sig |
| SECONDARY Cumulative Incidence of Thyroid Disorders- Goitre |
1.6; 2.5; 3.8 | <0.01 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01416194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.