The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with bone turnover markers as a Measure of bone quality
研究概览
简要总结
In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.
详细描述
Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Osteoporosis
- •Must be able to swallow tablets
排除标准
- 未提供
研究组 & 干预措施
Non-Alfacaocidol
Ahead of Eldecalcitol treatment, this group has not taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient.
干预措施: Edirol (Drug)
Alfacalcidol
Ahead of Eldecalcitol treatment, this group has taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient.
干预措施: Edirol (Drug)
结局指标
主要结局
Number of Participants with bone turnover markers as a Measure of bone quality
时间窗: At 1 year after the initial treatment
Bone formation and bone absorption markers will be evaluated at each time point
次要结局
- Number of Participants with bone mineral density as a Measure of bone quality(At 1 year after the initial treatment)
研究者
Yukio Nakamura
Assistant Professor
Shinshu University