EUCTR2015-005529-37-DK进行中（未招募）1 期
Treatment with zoledronic acid subsequent to denosumab in osteoporosis
Bente Lomholt Langdahl0 个研究点目标入组 60 人开始时间: 2015年12月15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
- 60
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
- 性别
- All
入选标准
- •Inclusion criteria
- •Postmenopausal women (postmenopausal for at least two years)
- •Men above 50 years
- •Treatment for at least two years with denosumab
- •Last denosumab injection less than five months ago
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Exclusion criteria
- •Low-energy vertebral fracture at any time
- •Low-energy hip fracture within the last 12 months
- •BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
- •Alendronate treatment for more than three years prior to denosumab treatment
- •Ongoing treatment with glucocorticoids
- •Metabolic bone disease
- •Hormone replacement therapy
- •Estimated glomerular filtration rate (eGFR) < 35 mL/min
- •Allergy to zoledronic acid
- •Hypocalcaemia
- •Contraindications for zoledronic acid according to the SPC
研究者
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