NCT00325468已完成3 期
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 200
- 主要终点
- Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
研究概览
简要总结
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must be ambulatory
- •Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
- •signed informed consent must be obtained before any study-specific procedures
排除标准
- •Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
- •Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
- •Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
- •Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
研究组 & 干预措施
AMG 162
Experimental
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
干预措施: AMG 162 (Drug)
结局指标
主要结局
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
时间窗: 8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
时间窗: 8 years
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
时间窗: 8 years
次要结局
- Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8(8 years)
- Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8(8 years)
研究者
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