EUCTR2007-001041-17-GR进行中（未招募）不适用
An Open, 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9月19日最近更新:
适应症
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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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)
- •- Receiving any investigational product other than denosumab
- •- 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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