Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treatment group Zoledronic Acid inj. 5mg/100mL |
Other: Zoledronic Acid injection, 5mg/100mL
Zoledronic Acid injection, 5mg/100mL
|
Outcome Measures
Primary Outcome Measures
- Rate of change in Bone Mineral Density (BMD) [48 weeks from baseline]
The Rate of change in Bone Mineral Density (BMD) of the lumbar vertebrae
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female adults 19 years of age or older at the time of screening visit
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A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission
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A person who can understand the information provided to the person and can voluntarily sign a written consent form
Exclusion Criteria:
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Those who are contraindicated in administration according to the approval of the research drug
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Persons participating in other clinical trials
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Those who have been judged by Investigator as unsuitable as subjects for this observational study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
- Principal Investigator: Yumie Lee, Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DWZA_OS01