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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

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Studies 759
Trials 63
Unknown PHASE4 INTERVENTIONAL NCT04524169

Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Change of VAS scores
TimeFrame: 4 week
Description: 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.

Trial Information

NCT ID

NCT04524169

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

RenJi Hospital

Last Updated

December 15, 2025