EUCTR2016-003228-22-NL进行中（未招募）1 期
Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study
niversity of Edinburgh0 个研究点目标入组 380 人开始时间: 2020年11月27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
- 380
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
- •Adult patients age 18 years and above with a clinical diagnosis of OI
- •Patients willing and able to consent and comply with the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Current or previous treatment with an investigational (non-licensed) drug with effects on bone metabolism.
- •Contraindication to TPTD or ZA
- •Women of childbearing potential not using highly effective methods of contraception (see below)
- •Women that are breastfeeding
- •Age <18 years
- •Women of childbearing potential (WOCBP) can be enrolled into the study but will be required to use highly effective methods of contraception (as defined by the HMA Clinical Trial Facilitation Group recommendations) before, during the trial if they are being treated with TPTD or bisphosphonates. Examples of highly effective contraception include:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Bilateral tubal occlusion
- •Vasectomised partner
- •True abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •Barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps with or without spermicidal foam/gel/film/cream/suppository) are not considered to be highly effective methods of contraception
研究者
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