A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Bone Mineral Density of the Lumbar Spine at 12 Months
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. Primary objective is the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region assessed by T-Score at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zoledronic Acid
Participants received zoledronic acid infusion in addition to calcium and vitamin D
干预措施: Zoledronic Acid (Drug)
Zoledronic Acid
Participants received zoledronic acid infusion in addition to calcium and vitamin D
干预措施: Calcium and Vitamin D combination (Dietary Supplement)
Placebo
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
干预措施: Placebo (Drug)
Placebo
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
干预措施: Calcium and Vitamin D combination (Dietary Supplement)
结局指标
主要结局
Change in Bone Mineral Density of the Lumbar Spine at 12 Months
时间窗: Screening (day -21 to -1) and month 12
Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
Change in Bone Mineral Density of the Total Hip Region at 12 Months
时间窗: Screening (day -21 to -1) and month 12
Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
次要结局
- Change in Bone Mineral Density of the Lumbar Spine at 6 Months(Screening (day -21 to -1) and month 6)
- Change in Bone Mineral Density of the Femoral Neck at 6 Months(Screening (day -21 to -1) and month 6)
- Change in Bone Mineral Density of the Total Hip at 6 Months(Screening (day -21 to -1) and month 6)
- Change in Bone Mineral Density of the Femoral Neck at 12 Months(Screening (day -21 to -1) and month 12)
- Change in Bone Mineral Density of the Lumbar Spine at 24 Months(Screening (day -21 to -1) and month 24)
- Change in Bone Mineral Density of the Total Hip Region at 24 Months(Screening (day -21 to -1) and month 24)
- Change in Bone Mineral Density of the Femoral Neck at 24 Months(Screening (day -21 to -1) and month 24)
- Course of Disease in Multiple Sclerosis Patients(Screening (day -21 to -1) and month 12)
- Adverse Events and Serious Adverse Events Comparison of Treatment Groups(24 months)