Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of VAS scores
研究概览
简要总结
Osteoporotic pain is the most common clinical symptom in elderly patients. The course of pain is prolonged and the effect of clinical treatment is limited. This study will observe the therapeutic effect of thymosin alpha 1 on elderly patient with osteoporotic pain and explore its immunotherapy mechanism.
详细描述
About 70% of the elderly patients suffered osteoporotic pain, mainly involving the limbs and low back. The pain prolonged and varies from mild to severe, and the effect of the clinical treatment is poor which has become a serious social problem. Recent studies have put forward a new point of "bone Immunology", which suggests that immune system, especially CD4+ T cell system, are involved in the regulation of bone formation, bone resorption and bone remodeling. So, in this study, the investigators will observe the therapeutic effect of thymosin alpha 1 on osteoporotic pain in elderly by observing the improvement of VAS score before and after the treatment, as well as the changes of proportion of peripheral blood CD4+ T lymphocyte subsets, bone mineral density, serum bone biochemical index, neuropeptides, RANKL and other cytokines levels will be evaluated. The clinical safety of thymosin alpha 1 in elderly patients with osteoporotic pain will also be observed.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffered osteoporotic pain diagnosed by specialists
- •VAS scores greater than 5
- •Normal reading and understanding ability
- •Communicate normally
- •Volunteer to participate
排除标准
- •Mental illness
- •Serious physical disease
- •Unwilling to cooperate
研究组 & 干预措施
Thymosin Alpha 1
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
干预措施: Thymosin Alpha1 (Drug)
结局指标
主要结局
Change of VAS scores
时间窗: 4 week
The VAS (visual analogue scale) is a scale used to determine the pain intensity experienced by individuals. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain", "0" means no pain, "10" means severe worst pain. In our study VAS score will be record before and after 4 weeks of treatment.
次要结局
- Change of BMD value(4 week)