ACTRN12609000399291已完成2 期
Patients with bone marrow oedema-associated knee pain, randomised to zolendronic acid or placebo, assessed by the amount of knee pain after three and twelve months.
Menzies Research Institue0 个研究点目标入组 60 人开始时间: 2009年6月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 100 Years（—）
- 性别
- All
入选标准
- •Knee Pain with bone marrow oedema on magnetic resonance imaging (MRI).
排除标准
- •Any prior use of bisphosphonate preparations, except according to the washout schedule:
- •2 years (if use >48 weeks)
- •1 year (if used >8 weeks but <48 weeks)
- •6 months (if used >2 weeks but <8 weeks)
- •2 months (if used <2 weeks)
- •Any intravenous bisphosphonate within the prior 2 years,
- •History of iritis or uveitis, except due to trauma, and resolved for >2 years prior to study
- •Serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL)
- •Serum 25-hydroxyvitamin D concentrations <15 ng/L
- •Use of any investigational drug(s) and/or devices within 30 days prior to randomization
- •creatinine clearance < 35 ml/min
- •Metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
- •A dental exam with appropriate preventative dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor hygiene)
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