NCT00718861已完成3 期
A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
研究概览
简要总结
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1
排除标准
- •Poor kidney, eye, liver health
- •Use of certain therapies for osteoporosis in study CZOL446H2301E1
- •Abnormal calcium levels
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo administered intravenously.
干预措施: Placebo (Drug)
Zoledronic acid
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9
时间窗: Year 6 (baseline) and Year 9
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\*(Year 9 - Year 6)/Year 6.
次要结局
- Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9(Year 6 (extension 2 baseline), Year 7, Year 8, Year 9)
- Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6(Year 6 (extension 2 baseline), Year 7, Year 8)
- Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0(Year 0 (core baseline), Year 7, Year 8, Year 9)
- Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9(Year 6 (extension 2 baseline), Year 7, Year 8, Year 9)
- Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9(Year 6 (extension 2 baseline), Year 7, Year 8, Year 9)
- Mean of Time to First Clinical Fracture(over 3 years of study duration)
- Change in Height at Years 7, 8 and 9 Relative to Year 6(Year 6 (extension 2 baseline), Year 7, Year 8, Year 9)
- Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0(Year 0 (core baseline), Year 7, Year 8, Year 9)
- Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6(Year 6 (extension 2 baseline), Year 7, Year 8, Year 9)
- Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6(Year 6 (extension 2 baseline), Year 9 (3 years of study duration))
研究者
研究点 (1)
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