2023-510198-32-00招募中4 期
Zoledronate Early to Hip Fractures Patients – safe and effective? A Randomized controlled double-blinded treatment strategy trial on Zoledronate in hip fracture patients: The ZEBRA trial
Oslo University Hospital HF3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年6月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Difference between the two groups in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate
研究概览
简要总结
To have zoledronate within 5 days (early) after hip fracture surgery is non-inferior to have zoledronate 3 months (late) after hip fracture surgery measured by the level of bone suppression estimated by the bone turnover marker P1NP 12 months after zoledronate treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •One low energy hip fracture
- •Surgery within 72 hours
- •>50 years old - Women age 50-60 must be postmenopausal or not pregnant
- •Acceptable kidney function (estimated GFR >35) and calcium levels
- •Fit to complete the follow-up judged by the recruiting physician
- •Signed informed consent by the patient or the next of kin
排除标准
- •Metal in the opposite hip
- •More than one acute fracture (concomitant fracture in addition to hip fracture)
- •Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatid, abaloparatid or romosozumab within the last 10 years
- •Glucocorticoid therapy, treatment with gnRH-analogs, aromatase-inhibitors, primary skeletal cancer or metastasis to the skeleton
- •Too sick to receive treatment with zoledronate judged by the recruiting or treating physician
- •Any other contraindication listed on the SmPC of the IMP(s) including pregnancy
- •Participating in another trial that might affect the current study
结局指标
主要结局
Difference between the two groups in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate
Difference between the two groups in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate
次要结局
- Grade of early mobilization measured by CAS score in hospital/at discharge from hospital
- Number of patients with delirium assessed by 4AT in hospital
- Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate
- Change in BMD 12 months after treatment with zoledronate
- Grade of mobilization and rehabilitation 3 months after fracture measured by TUG test
- Number of patients with fever (T> 38’C) in hospital
- Number of patients treated with antibiotics in hospital
- Time to discharge from hospital after admission and after the hip fracture surgery
- Time to and number of readmissions to hospital (any department)
- Time to and number of new fractures
- Time to and number of deaths
研究者
Lene Bergendal Solberg
Scientific
Oslo University Hospital HF
研究点 (3)
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