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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793142
• Other study ID #: B1781047
• Status: Completed
• Start date: October 24, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Description:

continuous enrollment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3430
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Viviant
Viviant (Bazedoxifene) 20mg once daily

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Sejong Hospital	Bucheon-Si	Gyeonggi-do
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon-Si	Gyeonggi-do
Korea, Republic of	Centum Hospital	Busan
Korea, Republic of	Dongrae Bongseng Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan-si	Chuncheongnam-do
Korea, Republic of	Sung Mo O.S	Daebang-dong	Seoul
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National Univ. Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital (CNUH)	Daejeon
Korea, Republic of	Daejeon St. Mary's Hospital-The Catholic University of Korea	Daejeon
Korea, Republic of	Eulji University Hospital	Daejeon	Republic OF Korea
Korea, Republic of	Wonju Severance Christian Hospital	Gangwon-do
Korea, Republic of	Inje University Ilsanpaik Hospital	Goyang	Gyeonggi-do
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Hosan OS Clinic	Goyang-si
Korea, Republic of	Il-San Gaspel Hospital	Goyang-Si	Gyeonggi-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	National Health Insurance Corporation Ilsan 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	Gwangju Veterans Hosptial	Gwangju-si
Korea, Republic of	Dongguk University Gyeongju Hospital	Gyeongju-si	Gyeongbuk
Korea, Republic of	Donguk University Gyeongju Hospital	Gyoungju
Korea, Republic of	Inje University Haeundae Paik Hospital	Haeundae-gu	Busan
Korea, Republic of	Wonkwang University Hospital	Iksan-si	Jeollabuk-do
Korea, Republic of	Christian Internal Medicine Clinic	Incheon
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Gyeongsang National University Hospital	Jinju-si	Gyeongsangnam-do
Korea, Republic of	Hanyang University Medical Center	Seongdong-ku	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center-University of Ulsan College of Medicine	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Choongmu Hospital	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Hongik Hospital	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Jung Dong Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kwangmyeong Sungae Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Severance Hospital, Yeonsei University Health System	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu
Korea, Republic of	Severance Hospital-Yonsei University College of Medicine	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul	Korea
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul	Capital Metropolitan
Korea, Republic of	Ajou University Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	St. Vincent's Hospital-The Catholic University of Korea	Suwon-si	Gyeonggi-do
Korea, Republic of	Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital	Wonju-Si	Gangwon-do
Korea, Republic of	Yangsan Hospital-Pusan National University	Yangsan-si	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Primary	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.	Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Secondary	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.	Baseline up to 3 months
Secondary	Number of Participants With Osteoporosis Related Fractures		Baseline up to 3 months
Secondary	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.	Baseline up to 3 months
Secondary	Number of Participants With Abnormal X-ray Result	Criteria for abnormality was based on investigator's discretion.	Baseline up to 3 months
Secondary	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.	Baseline up to 3 months
Secondary	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.	Baseline up to 3 months

External Links

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