Osteoporosis
Conditions
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.
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.
Interventions
OTHERZoledronic Acid injection, 5mg/100mL
Zoledronic Acid injection, 5mg/100mL
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female adults 19 years of age or older at the time of screening visit 2. A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission 3. A person who can understand the information provided to the person and can voluntarily sign a written consent form
Exclusion criteria
1. Those subject to contraindications to administration according to the drug approval requirements for research * Patients with hypersensitivity to the components of this drug or other bisphosphonate drugs Hypocalcemia * Patients with severe renal impairment whose creatinine clearance rate is less than 35 mL/min (patients must measure serum creatinine and creatinine clearance before receiving the study drug). * Patients receiving Zometa for cancer as an indication * Pregnant women, women who may be pregnant, and lactating women 2. 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.) 3. In addition to the above, patients whom the researcher (physician in charge) determines are not suitable as subjects of this observational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar spine bone mineral density (BMD) change rate | 48 weeks | Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) | 48 weeks | Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) at 48 weeks compared to baseline |
| New clinical fracture incidence | 48 weeks | New clinical fracture incidence at 48 weeks (%) |
| Investigator satisfaction score | 48 weeks | Investigator satisfaction score at 48 weeks |
| Safety evaluation | 48 weeks | Safety evaluation related to Daewoong zoledronic acid administration |
Countries
South Korea
Outcome results
None listed