Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

NCTNCT04524169Other idOP pain - Immunotherapy

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 100 participants (estimated)
Sponsor: RenJi Hospital · Other
Design: Randomized · Double masking
Countries: 1 country
China
Start: 1 Nov 2020 (estimated)
Primary completion: 31 Dec 2021 (estimated)
Completion: 31 Dec 2021 (estimated)
First posted: 24 Aug 2020
Last update posted: 26 Aug 2020
Conditions: Osteoporotic Pain

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 4
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
NCT04524169
est. 1 Nov 2020 to est. 31 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Thymosin Alpha1Drug

Arms2

Experimental
Thymosin Alpha 1
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
No intervention
Standard Care
Participants under the regularly treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

Change of VAS scores
Time frame · 4 week
Registry 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.

Secondary outcomes(1)

Change of BMD value
Time frame · 4 week
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 60 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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