ACTRN12617000545369招募中2 期
Effect of denosumab and zoledronic acid on bone turnover markers in critically ill women - A safety and feasibility, randomised, placebo controlled trial
niversity Hospital Geelong0 个研究点目标入组 30 人开始时间: 2017年4月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Admitted to ICU
- •3. Age >50 years or postmenopausal (amenorrhea for greater than 6-months or serum FSH >40mIU/L) or age < 50 years with bilateral salpingo-oopherectomy
- •4. Intensive care unit length of stay > 24 hrs
排除标准
- •1.Active malignancy
- •2.Metabolic bone disease
- •3.Pregnancy
- •4.Current eGFR <30ml/min
- •5.Known contraindication to denosumab (previous reaction, osteonecrosis of the jaw, atypical femoral fracture)
- •6.Increased risk of osteonecrosis (poor dentition or oral hygiene, dental infection)
- •7.Hypoparathyroidism
- •8.Malabsorption sydnromes / extensive small bowel resection
- •9.Current treatment with anti-fracture agent (bisphosphonate, strontium, teriparatide, within previous 2 years or denosumab within previous 6 months)
- •10.Current indication for anti-fracture therapy (known BMD T-score < -2.5 and fragility fracture)
- •11.Death is imminent or expected in this hospital admission
研究者
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