Osteoporotic Pain
Conditions
Keywords
osteoporotic pain, Thymosin alpha 1
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
DRUGThymosin Alpha1
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of VAS scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of BMD value | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of The CD4+ T-lymphocyte profile in peripheral blood | 4 week | Lymphocytes in peripheral blood were isolated from participants before and after 4 weeks of treatment. The CD4+ T-lymphocyte profile was analyzed by flow cytometry. |
Countries
China
Contacts
Primary ContactJie Xiao, MD,PHD
Backup ContactDiansan Su, MD,PHD
Outcome results
None listed