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临床试验/NCT02993029
NCT02993029招募中不适用

99Tc-MDP Versus Celecoxib Treatment in Patients With Knee Osteoarthritis

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
pain, stiffness and joint function of knee

研究概览

简要总结

Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has received growing attention in the society because of the increase of old age population, disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.

详细描述

The prevalence of osteoarthritis of the knee (OA) is increasing worldwide and this burden will continue to increase owing to aging of the general population 99Tc-MDP is effective for rheumatoid arthritis. Consequent to an increase in incidence is the rise in the number of patients with knee OA who are prone to further deterioration of the knee. It therefore is important to better understand, control, and attempt to prevent further progression of disease in patients with knee OA. Limitations in walking, stair climbing, and squatting are common patient complaints that greatly interfere with activities of daily living and recreation. Currently there is no definite consensus on the standardized management of OA. Oral analgesic and anti-inflammatory agents are perhaps the most commonly prescribed treatments to alleviate knee OA symptoms. The failure of nonsurgical therapies to modify quality of life in knee OA patients is not surprising given their inability to alleviate physical manifestations of OA. Surgical knee OA interventions generally result in good to excellent patient outcomes. However, there are significant barriers to considering surgery, which limits clinical utility.

99Tc-MDP is actually the decay product of 99mTc-MDP (99mTc-methylene diphosphonate, a US Food and Drug Administration-approved radioactive agent widely used for bone scintigraphy). 99Tc-MDP (Chengdu Yunke Pharmaceutical, Sichuan, China) is a kind of anti-inflammatory drug patented in China (patent no. ZL94113006.1). It was approved for production by the State Food and Drug Administration of China in October 1997. 99Tc-MDP has been demonstrated to be safe and effective in the clinical treatment of immune diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis (AS) and certain bone diseases, such as skeletal metastases from cancer in China. 99Tc-MDP also showed clinical effect on knee OA in our practice. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with painful osteoarthritis;
  • The standard uptake value (SUV) of OA related knee greater than 10 on 18F- sodium fluoride bone scan;
  • Participants voluntarily participate in the trial, and signed the informed consent.

排除标准

  • Knee joint replacement;
  • Inflammatory arthritis or joint infection of knee;
  • Nervous joint disease;
  • Fracture of joint;
  • Gout arthritis of the knee;
  • Traumatic arthritis.

研究组 & 干预措施

celecoxib

Active Comparator

celecoxib capsule 200mg qd by mouth.

干预措施: Celecoxib (Drug)

99Tc-MDP

Experimental

99Tc-MDP group:15mg in 100ml normal saline intravenously dripped every twice a week for 5 weeks, every 1weeks for 10 weeks, every 2weeks for 10 weeks, every 1 month for 6 months.

干预措施: 99Tc-MDP (Drug)

结局指标

主要结局

pain, stiffness and joint function of knee

时间窗: baseline, and 6, 12 months after treatment.

change of the pain, stiffness and joint function of knee (mean and standard deviation) by Western Ontario and McMaster Universities (WOMAC)Osteoarthritis Index

次要结局

  • standard uptake value of knee(baseline and 12 months after treatment.)
  • adverse events(3, 6, 12 months after treatment.)
  • health-related quality of life(baseline, and 6, 12 months after treatment.)
  • staging of knee osteoarthritisby(baseline and 12 months after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chao Ma

Professor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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