Effects of Denosumab Therapy for Japanese Osteoporotic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- BMD increase by denosumab in Japanese
研究概览
简要总结
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.
详细描述
Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).
Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoporotic patients
排除标准
- •cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)
结局指标
主要结局
BMD increase by denosumab in Japanese
时间窗: Up to 48 months
The investigators evaluate BMD increase by denosmab in Japanese patients.
次要结局
- Effects of previous therapy to denosumab(Up to 48 months)
- The determinants related to BMD increase and fracture prevention for denosumab treatment(Up to 48 months)
研究者
Toshihiko Kono
Head of Hospital
Tomidahama Hospital