ACTRN12621000085875招募中2 期
Effect of Zoledronic Acid or Denosumab on Bone Loss in Critically Ill Adults – A Randomised Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Female aged 50 years or older or male aged 70 years or older
- •Has been in ICU for 2 or more calendar days and is not expected to be discharged from ICU on the second day
- •Has required ICU level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at FiO2>0.4 and/or gas flows >40L/m) for a minimum cumulative duration of 6-hours
- •Expected to survive the current hospital admission
排除标准
- •Cancer related metastatic bone disease or multiple myeloma
- •Paget's disease
- •Current eGFR <30ml/min or receiving renal replacement therapy
- •Known contraindication to denosumab or zoledronic acid
- •Obvious holes in teeth or broken teeth or dental or gum infection
- •Known untreated hypoparathyroidism
- •Current treatment with bisphosphonate, strontium or teriparatide within previous 2 years, or menopausal hormone therapy or romosozumab within previous 12-months or denosumab within previous 6 months
- •Current fragility fracture of hip, spine, femur or forearm
- •Weight >120 kg or unable to undertake BMD for any reason
- •INR>3 or Platelet count <30,000.
研究者
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