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

NCT01793142 | Completed Results

• 1 other identifier: B1781047
• Study Type: observational
• Target: 3,430
• Locations: 1 country
• Sites: 60

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

Conditions

Osteoporosis

Keywords

Osteoporosis; postmenopausal; SERM

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Overall Efficacy Evaluation of Viviant 20 mg Tablet

  Baseline up to 3 months

• 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

• Number of Participants With Abnormal X-ray Result

  Baseline up to 3 months

• Number of Participants With Abnormal Bone Mineral Density Result

  Baseline up to 3 months

Study Arms (1)

Viviant treatment group

Viviant treatment group

Drug: Viviant

Interventions

Viviant DRUG

Viviant (Bazedoxifene) 20mg once daily

Viviant treatment group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal osteoporosis and osteopenia patients

You may qualify if:

• Postmenopausal osteoporosis and osteopenia patients

You may not qualify if:

• Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
• Patients with pulmonary embolism and retinal vein thrombosis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (60)

Inje University Haeundae Paik Hospital

Haeundae-gu, Busan, 48108, South Korea

Location

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, Capital Metropolitan, 06591, South Korea

Location

Dankook University Hospital

Cheonan-si, Chuncheongnam-do, 31116, South Korea

Location

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Sejong Hospital

Bucheon-si, Gyeonggi-do, 422-807, South Korea

Location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Inje University Ilsanpaik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Il-San Gaspel Hospital

Goyang-si, Gyeonggi-do, 410-831, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

Wonkwang University Sanbon Hospital

Gunpo, Gyeonggi-do, 15865, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

St. Vincent's Hospital-The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Dongguk University Gyeongju Hospital

Gyeongju, Gyeongsangbuk-do, 780-350, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Yangsan Hospital-Pusan National University

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Wonkwang University Hospital

Iksan-si, Jeollabuk-do, 54538, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, Korea, 04401, South Korea

Location

Eulji University Hospital

Daejeon, Republic of Korea, 35233, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun-gu, 03722, South Korea

Location

Hanyang University Medical Center

Seongdong-ku, Seoul, 133-792, South Korea

Location

Sung Mo O.S

Taebang-dong, Seoul, 156-808, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Dongrae Bongseng Hospital

Busan, 607-712, South Korea

Location

Centum Hospital

Busan, 613-812, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Kyungpook National Univ. Hospital

Daegu, 700-721, South Korea

Location

Daejeon St. Mary's Hospital-The Catholic University of Korea

Daejeon, 34943, South Korea

Location

Chungnam National University Hospital (CNUH)

Daejeon, 35015, South Korea

Location

Wonju Severance Christian Hospital

Gangwon-do, 220-701, South Korea

Location

Hosan OS Clinic

Goyang-si, 412-821, South Korea

Location

Gwangju Veterans Hosptial

Gwangju, 62284, South Korea

Location

Donguk University Gyeongju Hospital

Gyoungju, 780-350, South Korea

Location

Gachon University Gil Hospital

Incheon, 21565, South Korea

Location

Christian Internal Medicine Clinic

Incheon, 22104, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yeonsei University Health System

Seoul, 03722, South Korea

Location

Severance Hospital-Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Cheil General Hospital & Women's Healthcare Center

Seoul, 04619, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center-University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul St. Mary Hospital, The Catholic University of Korea

Seoul, 06591, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Choongmu Hospital

Seoul, 07301, South Korea

Location

Seoul Medical Center

Seoul, 131-865, South Korea

Location

Kwangmyeong Sungae Hospital

Seoul, 14241, South Korea

Location

Hongik Hospital

Seoul, South Korea

Location

Jung Dong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: October 24, 2013
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: December 24, 2018
• Results First Posted: December 24, 2018

Record last verified: 2018-05

Locations

KR (60)