Clinical trial NCT01793142: Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
Official title: Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis
postmenopausal
SERM
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 3430
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal osteoporosis and osteopenia patients

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

Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
measure: Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
timeFrame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Secondary outcomes:
measure: Overall Efficacy Evaluation of Viviant 20 mg Tablet
timeFrame: Baseline up to 3 months
measure: Number of Participants With Osteoporosis Related Fractures
timeFrame: Baseline up to 3 months
measure: Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)
timeFrame: Baseline up to 3 months
measure: Number of Participants With Abnormal X-ray Result
timeFrame: Baseline up to 3 months
measure: Number of Participants With Abnormal Bone Mineral Density Result
timeFrame: Baseline up to 3 months
measure: Number of Participants With Abnormal Biochemical Markers of Bone Turnover
timeFrame: Baseline up to 3 months
Other outcomes:
Locations:
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
state: Capital Metropolitan
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital
state: Chuncheongnam-do
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
state: Gangwon-do
city: Gyeongju-si
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
state: Gyeongbuk
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Bucheon-Si
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi-do
city: Bucheon-Si
country: Korea, Republic of
facility: Sejong Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Goyang-Si
country: Korea, Republic of
facility: Il-San Gaspel Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsanpaik Hospital
state: Gyeonggi-do
city: Gunpo-si
country: Korea, Republic of
facility: Wonkwang University Sanbon Hospital
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital-The Catholic University of Korea
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Yangsan-si
country: Korea, Republic of
facility: Yangsan Hospital-Pusan National University
state: Gyeongsangnam-do
city: Iksan-si
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
state: Korea
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
state: Republic OF Korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemun-gu
city: Daebang-dong
country: Korea, Republic of
facility: Sung Mo O.S
state: Seoul
city: Seongdong-ku
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Seoul
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Dongrae Bongseng Hospital
city: Busan
country: Korea, Republic of
facility: Centum Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ. Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital-The Catholic University of Korea
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNUH)
city: Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Goyang-si
country: Korea, Republic of
facility: Hosan OS Clinic
city: Gwangju-si
country: Korea, Republic of
facility: Gwangju Veterans Hosptial
city: Gyoungju
country: Korea, Republic of
facility: Donguk University Gyeongju Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Christian Internal Medicine Clinic
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yeonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Severance Hospital-Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Choongmu Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Kwangmyeong Sungae Hospital
city: Seoul
country: Korea, Republic of
facility: Hongik Hospital
city: Seoul
country: Korea, Republic of
facility: Jung Dong Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: