OsteoporosisNCT01793142
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
An observational study of Osteoporosis, run by Pfizer at 60 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Viviant
- How many people
- 3,430 participants
- Where
- 60 sitesSouth Korea
- Study dates
- 24 Oct 2013to 31 May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal osteoporosis and osteopenia patients
Who may be able to join
- Postmenopausal osteoporosis and osteopenia patients
Who cannot join
- Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
- Patients with pulmonary embolism and retinal vein thrombosis
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
South Korea60 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Sejong Hospital
Bucheon-si, Gyeonggi-do, 422-807
Pusan National University Hospital
Busan, 49241
Dongrae Bongseng Hospital
Busan, 607-712
Centum Hospital
Busan, 613-812
Dankook University Hospital
Cheonan-si, Chuncheongnam-do, 31116
Keimyung University Dongsan Hospital
Daegu, 41931
Kyungpook National Univ. Hospital
Daegu, 700-721
Eulji University Hospital
Daejeon, Republic of Korea, 35233
Daejeon St. Mary's Hospital-The Catholic University of Korea
Daejeon, 34943
Chungnam National University Hospital (CNUH)
Daejeon, 35015
Wonju Severance Christian Hospital
Gangwon-do, 220-701
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Inje University Ilsanpaik Hospital
Goyang-si, Gyeonggi-do, 10380
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Il-San Gaspel Hospital
Goyang-si, Gyeonggi-do, 410-831
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 411-706
Hosan OS Clinic
Goyang-si, 412-821
Wonkwang University Sanbon Hospital
Gunpo, Gyeonggi-do, 15865
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
Gwangju Veterans Hosptial
Gwangju, 62284
Dongguk University Gyeongju Hospital
Gyeongju, Gyeongsangbuk-do, 780-350
Donguk University Gyeongju Hospital
Gyoungju, 780-350
Inje University Haeundae Paik Hospital
Haeundae-gu, Busan, 48108
Wonkwang University Hospital
Iksan-si, Jeollabuk-do, 54538
Gachon University Gil Hospital
Incheon, 21565
Christian Internal Medicine Clinic
Incheon, 22104
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
Hanyang University Medical Center
Seongdong-ku, Seoul, 133-792
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Capital Metropolitan, 06591
Soon Chun Hyang University Hospital Seoul
Seoul, Korea, 04401
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722
Inje University Sanggye Paik Hospital
Seoul, 01757
Kyung Hee University Hospital
Seoul, 02447
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yeonsei University Health System
Seoul, 03722
Severance Hospital-Yonsei University College of Medicine
Seoul, 03722
Cheil General Hospital & Women's Healthcare Center
Seoul, 04619
Hanyang University Seoul Hospital
Seoul, 04763
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center-University of Ulsan College of Medicine
Seoul, 05505
Asan Medical Center
Seoul, 05505
Seoul St. Mary Hospital, The Catholic University of Korea
Seoul, 06591
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
SMG-SNU Boramae Medical Center
Seoul, 07061
Choongmu Hospital
Seoul, 07301
Seoul Medical Center
Seoul, 131-865
Kwangmyeong Sungae Hospital
Seoul, 14241
Hongik Hospital
Seoul
Jung Dong Hospital
Seoul
St. Vincent's Hospital-The Catholic University of Korea
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Sung Mo O.S
Taebang-dong, Seoul, 156-808
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Yangsan Hospital-Pusan National University
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: 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
Read the detailed description
continuous enrollment
- Conditions
- Osteoporosis
- Being tested
- Viviant
- Keywords
- Osteoporosis, postmenopausal, SERM
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViviantDrug
Viviant (Bazedoxifene) 20mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Viviant treatment group | Viviant treatment group Receives: Drug: Viviant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: 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
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.
Measured: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Secondary outcomes (6)
Overall Efficacy Evaluation of Viviant 20 mg Tablet
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.
Measured: Baseline up to 3 months
Number of Participants With Osteoporosis Related Fractures
Measured: Baseline up to 3 months
Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)
DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Measured: Baseline up to 3 months
Number of Participants With Abnormal X-ray Result
Criteria for abnormality was based on investigator's discretion.
Measured: Baseline up to 3 months
Number of Participants With Abnormal Bone Mineral Density Result
A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Measured: Baseline up to 3 months
Number of Participants With Abnormal Biochemical Markers of Bone Turnover
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.
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start24 Oct 2013
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793142
- Sponsor's protocol ID
- B1781047
- Status last verified
- May 2018
- First submitted
- 13 Feb 2013
- Last updated
- 24 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
- ClinicalTrials.gov ID
- NCT01793142
- Acronym / sponsor ID
- B1781047
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, postmenopausal, SERM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,430 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2013 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 24 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
continuous enrollment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viviant treatment group | – | Drug: ViviantViviant treatment group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal osteoporosis and osteopenia patients
Key inclusion criteria (1 listed)
- Postmenopausal osteoporosis and osteopenia patients
Key exclusion criteria (2 listed)
- Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
- Patients with pulmonary embolism and retinal vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViviantViviant (Bazedoxifene) 20mg once daily | Drug | Viviant treatment group |
Primary outcome
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.
6 secondary outcomes
Overall Efficacy Evaluation of Viviant 20 mg Tablet
Time frame: Baseline up to 3 months
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
Number of Participants With Abnormal X-ray Result
Time frame: Baseline up to 3 months
Number of Participants With Abnormal Bone Mineral Density Result
Time frame: Baseline up to 3 months
Number of Participants With Abnormal Biochemical Markers of Bone Turnover
Time frame: Baseline up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Pfizer at 60 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.