Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Osteoporotic Pain

Treatments: Drug: Thymosin Alpha1

Study type: Interventional

Funder types: Other

Identifiers

NCT04524169

OP pain - Immunotherapy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffered osteoporotic pain diagnosed by specialists
• VAS scores greater than 5
• Normal reading and understanding ability
• Communicate normally
• Volunteer to participate

Exclusion criteria

• Mental illness
• Serious physical disease
• Unwilling to cooperate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Thymosin Alpha 1

Experimental group

Description:

Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.

Treatment:

Drug: Thymosin Alpha1

Standard Care

No Intervention group

Description:

Participants under the regularly treatment