EUCTR2019-001650-26-DK进行中（未招募）1 期
Zoledronic acid for prevention of bone loss after bariatric surgery
Hospital South West Jutland0 个研究点目标入组 70 人开始时间: 2019年9月10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
- 70
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
- •Eligible for bariatric surgery according to current Danish National Guidelines*
- •Women or men
- •35 years or older
- •*The National Danish Guideline for Bariatric Surgery currently includes either 1: BMI=50 kg/m2, 2: BMI=35 kg/m2 and an obesity related comorbid condition of type 2 diabetes, sleep apnea, arthrosis of the hip or knee, polycystic ovary syndrome with an unmet wish for pregnancy or treatment resistant hypertension or 3: BMI=40 kg/m2 with an obesity related health risk other than those specified in 2.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy or breastfeeding.
- •Chronic kidney disease with estimated GFR<45 ml/min.
- •Hypocalcemia defined as an ionized calcium <1.18 mmol/l.
- •Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water.
- •Metabolic bone disease or treatment with anti-osteoporotic agents.
- •Current treatment with oral glucocorticoids or other drugs with effects on bone metabolism
- •Other diseases with known effects on bone metabolism
研究者
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