ACTRN12613000039785已完成3 期
Patients with knee pain, knee osteoarthritis and bone marrow lesions, randomised to zoledronic acid or placebo, assessed by knee cartilage volume loss over 24 months, knee pain at 3, 6, 12, 18, and 24 months, and bone marrow lesion size over 6 and 24 months
Menzies Research Institute Tasmania, University of Tasmania0 个研究点目标入组 264 人开始时间: 2013年1月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
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
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Males and females with significant knee pain on most days (defined as a pain score >= 40 mm on a 100-mm visual analogue scale (VAS)).
- •2) Aged >= 50 years old.
- •3) Bone marrow lesions present on MRI.
- •4) Meeting the American College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis.
排除标准
- •1)Prior use of bisphosphonates, 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 IV bisphosphonate within the prior 2 years
- •2)History of non-traumatic iritis or uveitis
- •3)Abnormal blood tests [serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL) or creatinine clearance < 35 ml/min]
- •4)Serum 25-hydroxyvitamin D concentrations <40 nmol/L
- •5)Use of any investigational drug(s) and/or devices within 30 days or 5 half-lives (whichever is longer) of the drug prior to randomisation
- •6)Prior diagnosis of cancer (metastatic cancer or cancer diagnosed < 2 years ago where treatment is still ongoing)
- •7)Poor dental fitness: 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)
- •8)Severe knee osteoarthritis (joint space narrowing (JSN)) on X-ray of Grade 3 using the Osteoarthritis Research Society International (OARSI) atlas)
- •9)Other forms of arthritis in which disease is active and concomitant medication is used (e.g. rheumatoid arthritis or other inflammatory arthritis)
- •10)Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months
- •11)Women who are pregnant or breast feeding
- •12)Patients who have had a corticosteroid injection in the last 3 months or a hyaluronic acid injection in the last 6 months in the index knee
- •13)Planned joint replacement surgery
- •14)Contraindication to MRI scanning (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for coil)
- •15)Inability to give informed consent
研究者
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