EUCTR2012-002216-10-EE
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
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoporosis in postmenopausal women
- 发起方
- Radius Health, Inc.
- 入组人数
- 1600
- 状态
- 进行中(未招募)
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
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- •1\.Subjects who were withdrawn from Study BA058\-05\-003 for any reason.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\.
结局指标
主要结局
未指定
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