Yonsei Severance Hospital
Seoul, South Korea
NCT Number: NCT05614778
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.
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Notify Me19 year and older
All sexes
Observational
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zoledronic Acid injection, 5mg/100mL
Time frame: 48 weeks
Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline
Time frame: 48 weeks
Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) at 48 weeks compared to baseline
Time frame: 48 weeks
New clinical fracture incidence at 48 weeks (%)
Time frame: 48 weeks
Investigator satisfaction score at 48 weeks
Time frame: 48 weeks
Safety evaluation related to Daewoong zoledronic acid administration
Daewoong Pharmaceutical Co. LTD.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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