NL-OMON30869撤回3 期
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 - Study to evaluate Denosumab in the treatment of postmenopausal osteoporosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Amgen
- 入组人数
- 62
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 99（—）
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
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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