NCT00377819已完成3 期
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) 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
- 504
- 主要终点
- Percent Change From Baseline in Total Hip Bone Mineral Density
研究概览
简要总结
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females 55 yrs or older
- •Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
- •Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4
排除标准
- •Vitamin D deficiency
- •Administration of intravenous bisphosphonate, or
- •fluoride (except for dental treatment) or
- •strontium ranelate
- •Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
- •Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening
研究组 & 干预措施
denosumab
Experimental
干预措施: Denosumab (AMG 162) (Drug)
alendronate
Active Comparator
干预措施: alendronate (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Hip Bone Mineral Density
时间窗: Baseline, 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.
次要结局
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density(Baseline, 12 months)
- Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)(Baseline, 3 months)
研究者
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