Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

NCT ID: NCT04524169

Last Updated: 2020-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporotic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thymosin Alpha 1

Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.

Group Type EXPERIMENTAL

Thymosin Alpha1

Intervention Type DRUG

Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.

Standard Care

Participants under the regularly treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thymosin Alpha1

Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Weifeng Yu

Role: STUDY_CHAIR

Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diansan Su

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jie Xiao, MD,PHD

Role: CONTACT

+86 13817931390

Diansan Su, MD,PHD

Role: CONTACT

+86 18616514088

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OP pain - Immunotherapy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Semaglutide on Bone Health
NCT07165158 NOT_YET_RECRUITING PHASE4