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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,881
- 试验地点
- 1
- 主要终点
- Lumbar spine bone mineral density (BMD) change rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults 19 years of age or older at the time of screening visit
- •A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission
- •A person who can understand the information provided to the person and can voluntarily sign a written consent form
排除标准
- •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
- •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.
结局指标
主要结局
Lumbar spine bone mineral density (BMD) change rate
时间窗: 48 weeks
Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline
次要结局
- Investigator satisfaction score(48 weeks)
- Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD)(48 weeks)
- New clinical fracture incidence(48 weeks)
- Safety evaluation(48 weeks)