NL-OMON55540尚未招募4 期
Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ
ACCORD0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
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), • Pregnancy, • 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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