NCT02578095已完成2 期
A Phase II, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Multi-Center Study to Explore the Efficacy, Safety and Tolerability of VK5211 in Subjects With Acute Hip Fracture
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 21
- 主要终点
- Efficacy in Hip Fracture Patients Confirmed by DXA Scan.
研究概览
简要总结
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.
Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation.
排除标准
- •Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo QD
干预措施: Placebo (Drug)
VK5211- 0.5mg
Experimental
0.5mgQD
干预措施: VK5211 (Drug)
VK5211- 1.0mg
Experimental
1.0mg QD
干预措施: VK5211 (Drug)
VK5211- 2.0mg
Experimental
2.0mg QD
干预措施: VK5211 (Drug)
结局指标
主要结局
Efficacy in Hip Fracture Patients Confirmed by DXA Scan.
时间窗: Baseline and Week12
Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.
次要结局
未报告次要终点
研究者
研究点 (21)
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