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

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

NCT01793142•Pfizer

View on ClinicalTrials.gov

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

Age

All ages

Sex

FEMALE

Healthy Volunteers

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

Locations (60)

Inje University Haeundae Paik Hospital

Haeundae-gu, Busan, South Korea

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

Seoul, Capital Metropolitan, South Korea

Dankook University Hospital

Cheonan-si, Chuncheongnam-do, South Korea

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Sejong Hospital

Bucheon-si, Gyeonggi-do, South Korea

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Inje University Ilsanpaik Hospital

Goyang-si, Gyeonggi-do, South Korea

National Health Insurance Corporation Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Key Dates

Start Date

October 24, 2013

Primary Completion Date

May 31, 2017

Completion Date

May 31, 2017

Last Updated

December 24, 2018

Enrollment

3,430

ACTUAL participants

Conditions

Osteoporosis

Interventions

Viviant

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device