Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
1 other identifier
interventional
100
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 26, 2020
August 1, 2020
1.2 years
August 11, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change of BMD value
4 week
Other Outcomes (1)
Change of The CD4+ T-lymphocyte profile in peripheral blood
4 week
Study Arms (2)
Thymosin Alpha 1
EXPERIMENTALThymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
Standard Care
NO INTERVENTIONParticipants under the regularly treatment
Interventions
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
Eligibility Criteria
You may qualify if:
- Patients suffered osteoporotic pain diagnosed by specialists
- VAS scores greater than 5
- Normal reading and understanding ability
- Communicate normally
- Volunteer to participate
You may not qualify if:
- Mental illness
- Serious physical disease
- Unwilling to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Diansan Su
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weifeng Yu
Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 24, 2020
Study Start
November 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 26, 2020
Record last verified: 2020-08