Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 7:54 AM
Study NCT ID:
NCT04524169
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of The CD4+ T-lymphocyte profile in peripheral blood', 'timeFrame': '4 week', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change of VAS scores', 'timeFrame': '4 week', '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.'}], 'secondaryOutcomes': [{'measure': 'Change of BMD value', 'timeFrame': '4 week', '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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoporotic pain', 'Thymosin alpha 1'], 'conditions': ['Osteoporotic Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffered osteoporotic pain diagnosed by specialists\n* VAS scores greater than 5\n* Normal reading and understanding ability\n* Communicate normally\n* Volunteer to participate\n\nExclusion Criteria:\n\n* Mental illness\n* Serious physical disease\n* Unwilling to cooperate'}, 'identificationModule': {'nctId': 'NCT04524169', 'briefTitle': 'Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain', 'orgStudyIdInfo': {'id': 'OP pain - Immunotherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thymosin Alpha 1', 'description': 'Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.', 'interventionNames': ['Drug: Thymosin Alpha1']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Participants under the regularly treatment'}], 'interventions': [{'name': 'Thymosin Alpha1', 'type': 'DRUG', 'description': 'Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.', 'armGroupLabels': ['Thymosin Alpha 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Diansan Su', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jie Xiao, MD,PHD', 'role': 'CONTACT', 'email': 'applexiaomz@163.com', 'phone': '+86 13817931390'}, {'name': 'Diansan Su, MD,PHD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+86 18616514088'}], 'overallOfficials': [{'name': 'Weifeng Yu', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}