EUCTR2007-001041-17-SE进行中（未招募）不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Amgen Inc.0 个研究点目标入组 5,600 人开始时间: 2007年7月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,600
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
- •Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60mg SC injection every 6 months.
- •Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit.
- •Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.
- •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 107
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4443
排除标准
- •- Permanently non-ambulatory subjects (use of an assistive device e.g. cane, walker etc is permitted)
- •- Missed two or more investigational product doses during the 20030216 study
- •- Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- •- Developed sensitivity to mammalian cell derived drug products during the 20030216 study
- •- Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
- •- Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
- •- Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone
- •- For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
研究者
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