N/A
N=3,430
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01793142 ↗Enrolled (actual)
3,430
Serious AEs
0.5%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 209; 17 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Viviant (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
209; 17 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs |
132; 3; 93 | — |
| SECONDARY Overall Efficacy Evaluation of Viviant 20 mg Tablet |
1283; 1814; 14; 0 | — |
| SECONDARY Number of Participants With Osteoporosis Related Fractures |
4 | — |
| SECONDARY Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) |
7 | — |
| SECONDARY Number of Participants With Abnormal X-ray Result |
— | — |
| SECONDARY Number of Participants With Abnormal Bone Mineral Density Result |
— | — |
| SECONDARY Number of Participants With Abnormal Biochemical Markers of Bone Turnover |
0; 0; 0 | — |
Summary
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs
Eligibility Criteria
Inclusion Criteria
- Postmenopausal osteoporosis and osteopenia patients
Exclusion Criteria
- Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
- Patients with pulmonary embolism and retinal vein thrombosis
Data sourced from ClinicalTrials.gov (NCT01793142). 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.