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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Zoledronic Acid inj. 5mg/100mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid injection, 5mg/100mL | Other | Zoledronic Acid injection, 5mg/100mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine bone mineral density (BMD) change rate | Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) | Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) at 48 weeks compared to baseline | 48 weeks |
| New clinical fracture incidence |
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Inclusion Criteria:
Exclusion Criteria:
Those subject to contraindications to administration according to the drug approval requirements for research
Patients participating in other clinical trials (However, registration is possible if you have not received investigational drugs or are participating in other non-interventional observational studies.)
In addition to the above, patients whom the researcher (physician in charge) determines are not suitable as subjects of this observational study.
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The Study population was calculated by using PASS16, Confidence intervals for one mean procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Yumie Lee | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Seoul | South Korea |
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New clinical fracture incidence at 48 weeks (%)
| 48 weeks |
| Investigator satisfaction score | Investigator satisfaction score at 48 weeks | 48 weeks |
| Safety evaluation | Safety evaluation related to Daewoong zoledronic acid administration | 48 weeks |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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