DRUG
Thymosin Alpha1
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
Status
Unknown
Phase
Phase 4
Enrollment
100
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 24, 2020
Study start
Nov 1, 2020
Primary completion
Dec 31, 2021
Study completion
Dec 31, 2021
Results posted
Not reported
Registry updated
Aug 26, 2020
Outcomes
What the study measures.
Primary outcomes
Change of VAS scores
Time frame · 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.
Secondary outcomes
Change of BMD value
Time frame · 4 week
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.
Eligibility
Who can take part.
- Minimum age
- 60 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Diansan Su
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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