A Randomized, Double-Blind, Placebo Controlled Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women With Intertrochanteric Fracture of the Hip
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16
研究概览
简要总结
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following surgery and to determine if ZT-031 is safe for patients with fractures. To be allowed in the study you have to have a type of hip fracture that requires surgery that is being studied (intertrochanteric fracture). You must also otherwise be in good health, with no serious diseases such as cancer, neurologic disease, other bone disease, liver, heart or kidney disease. You must be able to inject yourself every day with the study medication using an injection pen, like that used for insulin injections.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
ZT-031
干预措施: ZT-031 (Drug)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16
时间窗: 16 weeks
次要结局
- Screw barrel impaction distance(16 weeks)
- Screw cut-out and/or other hardware failure(16 weeks)
- Incidence of fracture non-union(16 weeks)
- Need for surgical revision with or without hardware removal(16 weeks)