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Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis

Osteoporosis Clinical Trial

Official title:
A Multicenter, Noninterventional, Prospective Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis in Real-world Observational Study

Clinical Trial Summary

This study is a non-interventional observational study. On the baseline (Visit 1), we collect demographic data from all participating subjects according to their daily medical conditions, prescribe drugs and collect validity and safety data according to the research plan in Visit 1 and Visit 2. In addition, we collect data by application on subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days.

Clinical Trial Description

The investigator will enroll subjects according to Inclusion/Exclusion criteria after obtaining Informed Consent Form from each subject. Enrolled subjects will administer Zoledronic Acid 5mg/100mL once on baseline (Visit 1). The demographic data, prescription data, and medical history, etc will be collected based on the approved protocol. Additionally using application, subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days will be collected. Investigator will also collect any occurrence of fracture through electronic medical record until 48 weeks (Visit 2) from baseline visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05614778
Study type Observational
Source Daewoong Pharmaceutical Co. LTD.
Contact Heejin Kim
Phone 010-9911-1728
Email hjkim221@daewoong.co.kr
Status Recruiting
Phase
Start date February 28, 2022
Completion date April 30, 2024
View Details
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