NCT00477217撤回2 期
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
研究概览
简要总结
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 40-85 years of age
- •Diagnosis of painful osteonecrosis of the knee within the last month.
排除标准
- •Intravenous (iv) bisphosphonates within the last 2 years.
- •Abnormal thyroid, kidney or liver function.
- •Abnormal blood calcium or alkaline phosphatase levels.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Other
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.
时间窗: 3 months
次要结局
- Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI.(6 months)
- Safety as assessed by adverse events.
研究者
研究点 (1)
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