Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
研究概览
简要总结
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoporosis patients
排除标准
- •not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
研究组 & 干预措施
BP plus ELD
To examine the effects of BP plus ELD in osteoporosis patients
干预措施: ELD "Edirol®Tablet 0.75ug" (Drug)
SERM plus ELD
To examine the effects of SERM plus ELD in osteoporosis patients
干预措施: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" (Drug)
SERM plus ELD
To examine the effects of SERM plus ELD in osteoporosis patients
干预措施: Bisphosphonates and ELD "Edirol®Tablet 0.75ug" (Drug)
SERM plus ELD
To examine the effects of SERM plus ELD in osteoporosis patients
干预措施: ELD "Edirol®Tablet 0.75ug" (Drug)
BP plus ELD
To examine the effects of BP plus ELD in osteoporosis patients
干预措施: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" (Drug)
BP plus ELD
To examine the effects of BP plus ELD in osteoporosis patients
干预措施: Bisphosphonates and ELD "Edirol®Tablet 0.75ug" (Drug)
ELD alone
To examine the effects of ELD alone in osteoporosis patients
干预措施: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" (Drug)
ELD alone
To examine the effects of ELD alone in osteoporosis patients
干预措施: Bisphosphonates and ELD "Edirol®Tablet 0.75ug" (Drug)
ELD alone
To examine the effects of ELD alone in osteoporosis patients
干预措施: ELD "Edirol®Tablet 0.75ug" (Drug)
结局指标
主要结局
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
时间窗: Change from Baseline Values of bone mineral density at 2 years in each group
次要结局
未报告次要终点
研究者
Yukio Nakamura
Lecturer at Shinshu University School of Medicine
Shinshu University