EUCTR2011-002811-27-DK进行中（未招募）1 期
The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment
Bente Langdahl, consultant, ass. professor, PhD, DMSc0 个研究点目标入组 80 人开始时间: 2011年11月4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
- 80
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
- •Inklusion criterias
- •Patients with OI type I and IV
- •Age 22 - 70 years
- •Informed consent
- •oLow BMD (T-score =/< -1.0) or =/<-1
- •For women: = 1 year postmenopausal
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exklusion criterias
- •Creatinine clearance < 30 mL/min
- •Previous treatment with PTH. Previous treatment with antiresorptives is not an exclusion criteria, but will be used for stratification of the patients
- •Treatment with glucocorticoids = 5mg daily during the last 3 months.
- •Metabolic bone disease or vitamin D deficiency.
- •Liver- or kidney disease
- •Existing contra indications for treatment with zoledronic acid or PTH
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