N/A
Completed N=3,187
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT01470326 ↗Enrolled (actual)
3,187
Serious AEs
3.1%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events — 137; 5 Participants
Summary
In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
137; 5 | — |
| PRIMARY Number of Participants With Any Fracture |
53 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
80 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events by Age |
25; 112 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events by Smoking Status |
0; 85; 52 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events by Use of Steroid |
13; 99; 25 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication |
66; 64; 7 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication |
101; 36 | — |
Eligibility Criteria
Inclusion Criteria
- Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.
Exclusion Criteria
- Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis
- Subject in long-term immovability (postoperative recovery, long-term bed rest)
- Subject with antiphospholipid antibody syndrome
Data sourced from ClinicalTrials.gov (NCT01470326). 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.