EUCTR2012-002216-10-LT进行中（未招募）1 期
An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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
- Female
入选标准
- •1.The subject was enrolled, randomized to BA058 Injection 80 µg/Placebo and completed 18-months of blinded treatment within Study BA058-05-003.
- •2.The subject is no more than 40 days from last study medication administration.
- •3.The subject has read, understood, and signed the written informed consent form for the Extension Study.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1.Subjects who were withdrawn from Study BA058-05-003 for any reason.
- •2.Subjects who experienced a treatment-related SAE during Study BA058-05-003.
研究者
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