NCT00165698已完成3 期
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
研究概览
简要总结
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
干预措施: menatetranone (Drug)
2
Active Comparator
干预措施: alfacalcidol (Drug)
结局指标
主要结局
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
时间窗: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
时间窗: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
时间窗: Baseline and 12 months
次要结局
- Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months(Baseline and 12 months)
- Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months(Baseline and 12 months)
- Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months(Baseline and 12 months)
- Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months(Baseline and 12 months)
- Height (Meter)(Baseline and 12 months)
- Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months(Baseline and 12 months)
- New Fracture and Fall(12 months)
研究者
研究点 (5)
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