NCT00293813已完成2 期
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium 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
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 247
- 主要终点
- Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
研究概览
简要总结
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
- •Must have low bone mineral density and meet specific eligibility criteria.
排除标准
- •Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
研究组 & 干预措施
3
Placebo Comparator
Placebo for denosumab and placebo for alendronate
干预措施: Placebo (Drug)
1
Experimental
denosumab and placebo for alendronate
干预措施: Denosumab (Drug)
2
Active Comparator
Placebo for denosumab and alendronate
干预措施: Alendronate (Drug)
结局指标
主要结局
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
时间窗: 12 months
Cortical Thickness measured by XtremeCT.
次要结局
- Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12(12 months)
研究者
相似试验
已完成
3 期
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate CancerHormone Refractory Prostate CancerNCT00286091Amgen1,435
已完成
3 期
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor TherapyBreast CancerNCT00556374Amgen3,420
进行中（未招募）
3 期
Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast CancerBreast CancerNCT03324932Kyoto Prefectural University of Medicine160
已完成
2 期
Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisNCT00095498Amgen227
已完成
3 期
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.Bone MetastasesNCT00321464Amgen2,049