Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT05804604
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2023-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-29', 'studyFirstSubmitDate': '2023-03-26', 'studyFirstSubmitQcDate': '2023-03-26', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of SHBG and comparison between intervention groups', 'timeFrame': '(Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine'}, {'measure': 'Serum concentration of CTX-I and comparison between intervention groups', 'timeFrame': '(Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine'}, {'measure': 'Serum concentration of CK-MB and comparison between intervention groups', 'timeFrame': '(Group 1) At the day of the admission to the Department of Orthopaedics and Rehabilitation prior the surgical treatment or (Group 2) at the day of the admission to the Department of Internal Medicine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proximal femur fracture', 'femoral neck fracture', 'pertrochanteric fracture', 'bone intake proteins', 'bone resorption', 'bone loss', 'muscle damage', 'muscle loss'], 'conditions': ['Femoral Neck Fractures', 'Pertrochanteric Fracture', 'Bone Resorption', 'Bone Loss', 'Muscle Loss', 'Muscle Damage']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to compare serum concentration of bone intake proteins \\[ sex hormone-binding globulin (SHBG), cross linked C-telopeptide of type I collagen (CTX-I)\\] and muscle atrophy marker \\[creatine kinase (CK-MB)\\] between patients after the fracture of proximal femur and their age corresponding counterpart without the fracture. The main question it aims to answer is:\n\n• Is the higher concentration of bone intake proteins and muscle atrophy marker a predictive factor of proximal femur fracture?\n\nThe part of participants (Group 1) will be hospitalized at the Department of Orthopaedics and Rehabilitation and will undergo a surgical treatment (open reduction of the fracture). The rest (Group 2) will be admitted to the Department of Internal Medicine. Participants of both Groups will have the blood sample test taken, to evaluate and compare the serum concentration of SHBG, CTX-I and CK-MB proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Department of Orthopaedics and Rehabilitation (due to proximal femur fracture) or to the Department of Internal Medicine (due to exacerbation of chronic disease process). The citizens of Warsaw in age over 65 who meet inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 65\n* Proximal femur fracture (Group 1)\n\nExclusion Criteria:\n\n* neoplasmatic history in the anamnesis,\n* prevalent fracture\n* mental illness\n* immune disease affecting protein balance'}, 'identificationModule': {'nctId': 'NCT05804604', 'briefTitle': 'Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Serum Concentration of Bone Intake Proteins and Muscle Decay Markers as Risk Factors of Proximal Femur Fractures', 'orgStudyIdInfo': {'id': 'WarsawMU/FOPF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture', 'description': 'Open reduction of femoral neck or pertrochanteric fracture and preoperative analysis of bone intake proteins and muscle atrophy marker serum concentration', 'interventionNames': ['Procedure: Surgical treatment of proximal femur fracture and blood sample test']}, {'label': 'Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture', 'description': 'Control group without a history of proximal femur fracture. Analysis of the bone intake proteins and muscle atrophy marker serum level', 'interventionNames': ['Procedure: Blood sample test']}], 'interventions': [{'name': 'Surgical treatment of proximal femur fracture and blood sample test', 'type': 'PROCEDURE', 'description': 'Open reduction of femoral neck or pertrochanteric fracture with hemi/total hip arthroplasty or gamma nail. Analysis of serum concentration of: SHBG, CTX - I, CK-MB', 'armGroupLabels': ['Level of bone intake proteins and muscle atrophy marker in patients after proximal femur fracture']}, {'name': 'Blood sample test', 'type': 'PROCEDURE', 'description': 'Analysis of serum concentration of: SHBG, CTX - I, CK-MB', 'armGroupLabels': ['Level of bone intake proteins and muscle atrophy marker in patients without proximal femur fracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-749', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Othopedics and Rehabilitation, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Artur Stolarczyk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}