- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470326
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) (VIOLINE)
March 13, 2018 updated by: Pfizer
Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
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.
Study Overview
Detailed Description
All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type
Observational
Enrollment (Actual)
3187
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
|
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Relatedness to Viviant was assessed by the physician.
|
3 years
|
Number of Participants With Any Fracture
Time Frame: 3 years
|
Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant.
The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Expectedness of the adverse event was determined according to the Japanese package insert.
Relatedness to Viviant was assessed by the physician.
|
3 years
|
Number of Participants With Treatment-Related Adverse Events by Age
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Relatedness to Viviant was assessed by the physician.
Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
3 years
|
Number of Participants With Treatment-Related Adverse Events by Smoking Status
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Relatedness to Viviant was assessed by the physician.
Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
3 years
|
Number of Participants With Treatment-Related Adverse Events by Use of Steroid
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Relatedness to Viviant was assessed by the physician.
Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
|
3 years
|
Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Relatedness to Viviant was assessed by the physician.
Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
|
3 years
|
Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
Time Frame: 3 years
|
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant.
Relatedness to Viviant was assessed by the physician.
Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2011
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 9, 2011
First Posted (Estimate)
November 11, 2011
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
March 13, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Bazedoxifene
Other Study ID Numbers
- B1781007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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