NCT01803360Unknown2 期
A Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy of Neridronate 100 mg -4 i.v. Infusions- in Patients With Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
ASST Gaetano Pini-CTO1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- knee pain reduction
研究概览
简要总结
The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee Osteoarthritis (ACR criteria)
- •Radiographic diagnosis of knee Osteoarthritis (Kellgren/Lawrence scale >=2)
- •>4 weeks but <3 months pain, reported as >30 mm on a 100 mm VAS scale
- •bone marrow oedema of the affected knee on magnetic resonance
排除标准
- •inflammatory arthritis
- •aseptic osteonecrosis of the knee
- •previous or current treatment with Bisphosphonates
- •serum calcium or creatinine abnormalities
研究组 & 干预措施
Neridronate
Experimental
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
干预措施: Neridronate (Drug)
结局指标
主要结局
knee pain reduction
时间窗: 60 days
to assess the efficacy in terms of proportion of patients with a 50% reduction in pain intensity compared to baseline measured by VAS 100 mm scale recorded at the last visit (day 60)
次要结局
- Bone marrow lesions reduction(60 days)
研究者
Massimo Varenna
MD PhD
ASST Gaetano Pini-CTO
研究点 (1)
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