Osteoporotic PainPhase 4NCT04524169
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
A Phase 4 study testing Thymosin Alpha1 in people with Osteoporotic Pain, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoporotic Pain
- What is being tested?
- Thymosin Alpha1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffered osteoporotic pain diagnosed by specialists
- VAS scores greater than 5
- Normal reading and understanding ability
- Communicate normally
- Volunteer to participate
Who cannot join
- Mental illness
- Serious physical disease
- Unwilling to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoporotic Pain
- Being tested
- Thymosin Alpha1
- Keywords
- osteoporotic pain, Thymosin alpha 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Alpha1Drug
Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Thymosin Alpha 1 | Experimental | Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks. Receives: Drug: Thymosin Alpha1 |
| Standard Care | No intervention | Participants under the regularly treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week
Secondary outcomes (1)
Change of BMD value
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic PainStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weifeng Yu, Study chair, Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524169
- Sponsor's protocol ID
- OP pain - Immunotherapy
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
- ClinicalTrials.gov ID
- NCT04524169
- Acronym / sponsor ID
- OP pain - Immunotherapy
- Conditions
- Osteoporotic Pain
- Keywords
- osteoporotic pain, Thymosin alpha 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymosin Alpha 1 | Experimental | Drug: Thymosin Alpha1Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks. |
| Standard Care | No intervention | –Participants under the regularly treatment |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffered osteoporotic pain diagnosed by specialists
- VAS scores greater than 5
- Normal reading and understanding ability
- Communicate normally
- Volunteer to participate
Key exclusion criteria (3 listed)
- Mental illness
- Serious physical disease
- Unwilling to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin Alpha1Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks. | Drug | Thymosin Alpha 1 |
Primary outcome
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.
1 secondary outcome
Change of BMD value
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu study chair
Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thymosin Alpha1 in people with Osteoporotic Pain, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Xiao, MD,PHD (+86 13817931390, applexiaomz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VAS scores (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.