Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT06643650
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-02-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-10-13', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Vitamin D levels of the patients after receiving vitamin D supplementation', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of 25(OH)D vitamin'}, {'measure': 'Evaluation of BMD of the patients after receiving vitamin D supplementation', 'timeFrame': '12 months', 'description': 'Measurement of Bone Mineral Density'}], 'secondaryOutcomes': [{'measure': 'PTH', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Parathyroid Hormone'}, {'measure': 'TSH', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Thyroid-stimulating Hormone'}, {'measure': 'Ca', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Calcium levels'}, {'measure': 'P', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Phosphorus levels'}, {'measure': 'ALP', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Alkaline phosphatase levels'}, {'measure': 'Al', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Albumin levels'}, {'measure': 'Mg', 'timeFrame': '1 month, 3 months, 6 months and 12 months', 'description': 'Measurement of blood test of Magnesium levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Osteoporosis', 'Bone Loss, Age-Related', 'Fracture of Hip']}, 'descriptionModule': {'briefSummary': 'Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Vitamin D and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture.\n\nThe goal of vitamin D supplementation is to bring the serum 25-(OH)-D concentration above 30 ng/ml.\n\nClinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. Pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition).\n\nThis is an observational cohort study that will record data on the use of vitamin D in daily practice in patients with low-energy fractures.\n\nThe aim of this study is to measure vitamin D levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years of age with a low energy fracture will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old\n* Patients with a low energy fracture\n* Vitamin D levels \\< 30 ng/ml\n* Patients with available medical history before and after initiation of study treatment\n* Patients providing informed consent for this study\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients receiving different osteoporosis treatment\n* Patients with known hypersensitivity to vitamin D\n* Patients participating in another similar study at the same time with other drugs\n* Patients with vitamin D contraindications according to the medical instructions for use\n* Patients with a fracture due to a traffic accident'}, 'identificationModule': {'nctId': 'NCT06643650', 'briefTitle': 'Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'PHASE IV Observational Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.', 'orgStudyIdInfo': {'id': '945/11-03-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose)', 'interventionNames': ['Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML']}, {'label': '2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol', 'interventionNames': ['Dietary Supplement: CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML']}], 'interventions': [{'name': 'CHOLECALCIFEROL ORAL.SOL 25000 IU/2,5ML', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['DELTIUS ORAL.SOL 25000 IU/2,5ML'], 'description': 'Cholecalciferol 25000IU/week for 3 months in both groups. 2nd group continues with 25000IU/month for following 3 months.', 'armGroupLabels': ['1st group: 3 months intake of cholecalciferol supplementation (therapeutic dose)', '2nd group: 3 months therapeutic and 3 months prophylactic dose intake of cholecalciferol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14561', 'city': 'Kifissia', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Efstathios Chronopoulos, Professor', 'role': 'CONTACT', 'email': 'stathi24@yahoo.gr', 'phone': '6944837793', 'phoneExt': '0030'}], 'facility': 'KAT General Hospital of Attika', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}], 'centralContacts': [{'name': 'Efstathios Chronopoulos, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'stathi24@yahoo.gr', 'phone': '6944837793', 'phoneExt': '0030'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedic Surgery', 'investigatorFullName': 'EFSTATHIOS CHRONOPOULOS', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}