Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
- Registration Number
- NCT01793142
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
continuous enrollment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3430
- Postmenopausal osteoporosis and osteopenia patients
- Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
- Patients with pulmonary embolism and retinal vein thrombosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Viviant treatment group Viviant Viviant treatment group
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) 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 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
Name Time Method Overall Efficacy Evaluation of Viviant 20 mg Tablet 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 Baseline up to 3 months Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) 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 Baseline up to 3 months Criteria for abnormality was based on investigator's discretion.
Number of Participants With Abnormal Bone Mineral Density Result 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 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.
Trial Locations
- Locations (60)
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Korea, Republic of
Sung Mo O.S
🇰🇷Daebang-dong, Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seongdong-ku, Seoul, Korea, Republic of
Centum Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Daejeon St. Mary's Hospital-The Catholic University of Korea
🇰🇷Daejeon, Korea, Republic of
Chungnam National University Hospital (CNUH)
🇰🇷Daejeon, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital-Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Haeundae-gu, Busan, Korea, Republic of
Sejong Hospital
🇰🇷Bucheon-Si, Gyeonggi-do, Korea, Republic of
Dongguk University Gyeongju Hospital
🇰🇷Gyeongju-si, Gyeongbuk, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Capital Metropolitan, Korea, Republic of
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
🇰🇷Wonju-Si, Gangwon-do, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Il-San Gaspel Hospital
🇰🇷Goyang-Si, Gyeonggi-do, Korea, Republic of
Wonkwang University Sanbon Hospital
🇰🇷Gunpo-si, Gyeonggi-do, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan-si, Jeollabuk-do, Korea, Republic of
Yangsan Hospital-Pusan National University
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Dongrae Bongseng Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National Univ. Hospital
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Republic OF Korea, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju-si, Gyeongsangnam-do, Korea, Republic of
Inje University Ilsanpaik Hospital
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
St. Vincent's Hospital-The Catholic University of Korea
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Korea, Republic of
Christian Internal Medicine Clinic
🇰🇷Incheon, Korea, Republic of
Donguk University Gyeongju Hospital
🇰🇷Gyoungju, Korea, Republic of
Hosan OS Clinic
🇰🇷Goyang-si, Korea, Republic of
Gwangju Veterans Hosptial
🇰🇷Gwangju-si, Korea, Republic of
Choongmu Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Hongik Hospital
🇰🇷Seoul, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan-si, Chuncheongnam-do, Korea, Republic of
Soon Chun Hyang University Bucheon Hospital
🇰🇷Bucheon-Si, Gyeonggi-do, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center-University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yeonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Kwangmyeong Sungae Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Jung Dong Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of