Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT06067932
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Foot Disorders in X-linked Hypophosphatemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053098', 'term': 'Familial Hypophosphatemic Rickets'}], 'ancestors': [{'id': 'D063730', 'term': 'Rickets, Hypophosphatemic'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007015', 'term': 'Hypophosphatemia, Familial'}, {'id': 'D015499', 'term': 'Renal Tubular Transport, Inborn Errors'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D017674', 'term': 'Hypophosphatemia'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of feet with signs of osteoarthritis', 'timeFrame': 'baseline', 'description': 'radiographic signs of osteoarthritis at the foot joints'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['foot and ankle'], 'conditions': ['X-linked Hypophosphatemia']}, 'descriptionModule': {'briefSummary': 'This study aimed to characterize foot pathologies using X-rays and clinical examination and assess related outcome scores in adolescents and adults with X-linked Hypophophatemia', 'detailedDescription': 'A single center, cross-sectional analysis of adolescent and adult patients with XLH with and without previous surgical intervention was performed at the Orthopaedic Hospital Speising, Vienna, Austria. Clinical examination, quality of life questionnaires and radiographic data of foot x-rays in standing position were collected. Radiographic evaluation was performed to analyze foot deformity as well as signs of osteoarthritis at the foot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rare bone disease (XLH) with and without foot problems', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Patients with confirmed XLH, ≥ 16 years were invited to participate in this study\n\nExclusion Criteria:\n\n* Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.'}, 'identificationModule': {'nctId': 'NCT06067932', 'briefTitle': 'Foot Disorders in X-linked Hypophosphatemia', 'organization': {'class': 'OTHER', 'fullName': 'Orthopedic Hospital Vienna Speising'}, 'officialTitle': 'Mid- and Forefoot Disorders in Adolescents and Adults With X-linked Hypophosphatemia', 'orgStudyIdInfo': {'id': 'Midfoot XLH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Foot X rays', 'type': 'RADIATION', 'description': 'Radiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint.'}, {'name': 'Clinical examination + scores', 'type': 'DIAGNOSTIC_TEST', 'description': 'The American Orthopedic Foot and Ankle Society Score (AOFAS- midfoot section and 1st Forefoot ray, Forefoot ray 2-5) and the foot function index (FFI) were assessed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Orthopedic Hospital Speising Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gabriel Mindler, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Orthopedic Hospital Speising Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthopedic Hospital Vienna Speising', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgeon', 'investigatorFullName': 'Forian Wenzel-Schwarz', 'investigatorAffiliation': 'Orthopedic Hospital Vienna Speising'}}}}