A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 2,456
- 试验地点
- 30
- 主要终点
- Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
研究概览
简要总结
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
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
- 68 Years 至 90 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.
排除标准
- •Poor kidney, eye, or liver health
- •Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
- •Abnormal calcium levels in the blood
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic Acid 6
Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
干预措施: Zoledronic Acid (Drug)
Zoledronic Acid 3 Placebo 3
Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
干预措施: Placebo (Drug)
Placebo 3 Zoledronic Acid 3
Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3
时间窗: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)
The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 \*(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).
次要结局
- Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP(Year 4.5)
- Bone Resorption and Formation Biochemical Markers at Year 6: P1NP(Year 6)
- Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54))
- Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6)
- Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54))
- Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72))
- Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54))
- Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72))
- Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures(Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6)
- Number of Participants With Incidence of Clinical Fracture(Extension Baseline (Year 3; Month 36) to Year 6)
- Qualitative Bone Biopsy Parameters(End of Study Visit at Year 6)
- Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion(Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion)
- Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion(Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion)
- Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion(Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion)
- The Number of Participants With Clinically Significant Laboratory Parameters(Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6)