Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

Conditions
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Osteoporotic Pain

Intervention / Treatment
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* Drug: Thymosin Alpha1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin Alpha 1<br>Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks. | Drug: Thymosin Alpha1<br>* Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.<br>|
| No Intervention: Standard Care<br>Participants under the regularly treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS scores | 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. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BMD value | A bone mineral density (BMD) test is an easy, reliable test that measures the thickness of the bones and the response to osteoporosis treatment. We perform the BMD test by X-rays and record participants' BMD values before and after 4 weeks of treatment. | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporotic pain, Thymosin alpha 1