NCT04524169

Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoporotic Pain

Interventions

Type	Name	Description
DRUG	Thymosin Alpha1	Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-08-24
• Last updated: 2020-08-26

Locations

1 site across 1 country: China