Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
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 bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
详细描述
Registry criteria: Patients treated in the investigators hospital using teriparatide. 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
- •severe osteoporotic patients
排除标准
- •cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)
结局指标
主要结局
Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
时间窗: Up to 36 months
The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment. We investigate changes in BMD and bone turnover markers.
次要结局
未报告次要终点
研究者
Toshihiko Kono
Head of Hospital
Tomidahama Hospital