EUCTR2014-004318-27-NO进行中（未招募）1 期
Intravenous bisphosphonate in stress fracture treatment -A randomised controlled double blinded multicenter trial
Oslo University Hospital0 个研究点目标入组 40 人开始时间: 2016年5月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Age 18-70 years
- •-Stress fractures in the foot. A stress fracture is defined as a fracture occured after repetitive trauma, with characteristic MRI findings (ref) and distinctive pain over the fracture site at weight bearing.
- •-at least 6 months of pain history
- •-compliant patient
- •-non-aided ambulatory patient prior to the injury
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •-Ongoing use of bisphosphonates, PTH/PTH-analogues or use within 12 months prior to the injury
- •-Use of bisphophonates for more than 6 months within the last 5 years
- •-Intolerance to zoledronic acid
- •-Renal failure (GFR<30)
- •-S-25(OH)vitD > 25
- •-pregnancy
- •-breast feeding
- •-hypocalcemia
- •-MRI contraindications
研究者
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