Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
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| ClinicalTrials.gov Identifier: NCT01793142 |
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Recruitment Status :
Completed
First Posted : February 15, 2013
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief 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
| Condition or disease | Intervention/treatment |
|---|---|
| Osteoporosis | Drug: Viviant |
| Study Type : | Observational |
| Actual Enrollment : | 3430 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice. |
| Actual Study Start Date : | October 24, 2013 |
| Actual Primary Completion Date : | May 31, 2017 |
| Actual Study Completion Date : | May 31, 2017 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Viviant treatment group
Viviant treatment group
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Drug: Viviant
Viviant (Bazedoxifene) 20mg once daily |
Primary Outcome Measures :
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months) ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
- Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs [ Time Frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months) ]An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.
Secondary Outcome Measures :
- Overall Efficacy Evaluation of Viviant 20 mg Tablet [ Time Frame: Baseline up to 3 months ]Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
- Number of Participants With Osteoporosis Related Fractures [ Time Frame: Baseline up to 3 months ]
- Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) [ Time Frame: Baseline up to 3 months ]DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
- Number of Participants With Abnormal X-ray Result [ Time Frame: Baseline up to 3 months ]Criteria for abnormality was based on investigator's discretion.
- Number of Participants With Abnormal Bone Mineral Density Result [ Time Frame: Baseline up to 3 months ]A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
- Number of Participants With Abnormal Biochemical Markers of Bone Turnover [ Time Frame: Baseline up to 3 months ]In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Postmenopausal osteoporosis and osteopenia patients
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793142
Locations
Show 60 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study Documents (Full-Text)
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01793142 |
| Other Study ID Numbers: |
B1781047 |
| First Posted: | February 15, 2013 Key Record Dates |
| Results First Posted: | December 24, 2018 |
| Last Update Posted: | December 24, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Pfizer:
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Osteoporosis postmenopausal SERM |
Additional relevant MeSH terms:
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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |