Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Total hip BMD change during a one-year treatment period
研究概览
简要总结
This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
详细描述
This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.
Primary outcome:
Total hip BMD change during a one-year treatment period.
Secondary outcome:
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
- •SCI of at least 24-month but less than 7 years duration,
- •American Spinal Injury Association (ASIA) Impairment Scale A-C
排除标准
- •myocardial infarction (MI) or stroke within the preceding year
- •high cardiovascular risk, 10 years Framingham score over 20 %.
研究组 & 干预措施
SC Romosozumab 210 mg/monthly
SC Romosozumab 210 mg/monthly
干预措施: Romosozumab (Drug)
IV Zoledronic acid 5 mg
IV Zoledronic acid 5 mg
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Total hip BMD change during a one-year treatment period
时间窗: one year
BMD change
次要结局
- Bone turnover markers change(one year)
- Change in Femoral neck BMD at 12 months(one year)
研究者
Dr. Liana Tripto Shkolnik
Deputy Director, Division of Endocrinology, Diabetes and Metabolism
Sheba Medical Center