Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

May 31, 2018 updated by: Pfizer

Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

continuous enrollment

Study Type

Observational

Enrollment (Actual)

3430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 607-712
        • DongRae BongSeng Hospital
      • Busan, Korea, Republic of, 613-812
        • Centum Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National Univ. Hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital (CNUH)
      • Daejeon, Korea, Republic of, 34943
        • Daejeon St. Mary's Hospital-The Catholic University of Korea
      • Gangwon-do, Korea, Republic of, 220-701
        • Wonju Severance Christian Hospital
      • Goyang-si, Korea, Republic of, 412-821
        • Hosan OS Clinic
      • Gwangju-si, Korea, Republic of, 62284
        • Gwangju Veterans Hosptial
      • Gyoungju, Korea, Republic of, 780-350
        • Donguk University Gyeongju Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Hospital
      • Incheon, Korea, Republic of, 22104
        • Christian Internal Medicine Clinic
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 06973
        • Chung-ang University Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 131-865
        • Seoul Medical Center
      • Seoul, Korea, Republic of, 04619
        • Cheil General Hospital & Women's Healthcare Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center-University of Ulsan College of Medicine
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yeonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital-Yonsei University College of Medicine
      • Seoul, Korea, Republic of, 06591
        • Seoul St. Mary Hospital, The Catholic University of Korea
      • Seoul, Korea, Republic of, 07301
        • Choongmu Hospital
      • Seoul, Korea, Republic of, 14241
        • Kwangmyeong Sungae Hospital
      • Seoul, Korea, Republic of
        • Hongik Hospital
      • Seoul, Korea, Republic of
        • Jung Dong Hospital
    • Busan
      • Haeundae-gu, Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
    • Capital Metropolitan
      • Seoul, Capital Metropolitan, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St.Mary's Hospital
    • Chuncheongnam-do
      • Cheonan-si, Chuncheongnam-do, Korea, Republic of, 31116
        • Dankook University Hospital
    • Gangwon-do
      • Wonju-Si, Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
    • Gyeongbuk
      • Gyeongju-si, Gyeongbuk, Korea, Republic of, 780-350
        • Dongguk university gyeongju hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-Si, Gyeonggi-do, Korea, Republic of, 14584
        • Soon Chun Hyang University Bucheon Hospital
      • Bucheon-Si, Gyeonggi-do, Korea, Republic of, 422-807
        • Sejong Hospital
      • Goyang, Gyeonggi-do, Korea, Republic of, 10380
        • Inje University ilsanPaik Hospital
      • Goyang-Si, Gyeonggi-do, Korea, Republic of, 410-831
        • Il-San Gaspel Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
        • Inje University Ilsan Paik Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
        • DongGuk University ilsan Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
        • Myongji Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10444
        • National Health Insurance Corporation Ilsan Hospital
      • Gunpo-si, Gyeonggi-do, Korea, Republic of, 15865
        • Wonkwang University Sanbon Hospital
      • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital-The Catholic University of Korea
    • Gyeongsangnam-do
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
        • Yangsan Hospital-Pusan National University
    • Jeollabuk-do
      • Iksan-si, Jeollabuk-do, Korea, Republic of, 54538
        • Wonkwang University Hospital
    • Korea
      • Seoul, Korea, Korea, Republic of, 04401
        • Soon Chun Hyang University Hospital Seoul
    • Republic OF Korea
      • Daejeon, Republic OF Korea, Korea, Republic of, 35233
        • Eulji University Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
    • Seoul
      • Daebang-dong, Seoul, Korea, Republic of, 156-808
        • Sung Mo O.S
      • Seongdong-ku, Seoul, Korea, Republic of, 133-792
        • Hanyang University Medical Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal osteoporosis and osteopenia patients

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Viviant treatment group
Drug: Viviant
Viviant (Bazedoxifene) 20mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
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.
Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 3 months
Number of Participants With Osteoporosis Related Fractures
Time Frame: Baseline up to 3 months
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.
Baseline up to 3 months
Number of Participants With Abnormal X-ray Result
Time Frame: Baseline up to 3 months
Criteria for abnormality was based on investigator's discretion.
Baseline up to 3 months
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.
Baseline up to 3 months
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.
Baseline up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

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.

Helpful Links

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)

October 24, 2013

Primary Completion (ACTUAL)

May 31, 2017

Study Completion (ACTUAL)

May 31, 2017

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1781047

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.

Clinical Trials on Osteoporosis

Clinical Trials on Viviant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe