Trials / Completed
CompletedNCT05614778
Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,881 (actual)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Zoledronic Acid injection, 5mg/100mL | Zoledronic Acid injection, 5mg/100mL |
Timeline
- Start date
- 2022-02-28
- Primary completion
- 2024-02-01
- Completion
- 2024-05-31
- First posted
- 2022-11-14
- Last updated
- 2024-10-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05614778. Inclusion in this directory is not an endorsement.