Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05544669
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013683', 'term': 'Telangiectasia, Hereditary Hemorrhagic'}, {'id': 'D017674', 'term': 'Hypophosphatemia'}, {'id': 'D010018', 'term': 'Osteomalacia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D002128', 'term': 'Calcium 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'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-07-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a bone crack and/or fracture', 'timeFrame': 'Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rendu-Osler disease', 'Hypophosphatemia', 'Injectable iron', 'Osteomalacia', 'Carbohydrates', 'Iron deficiency'], 'conditions': ['Rendu Osler Disease']}, 'descriptionModule': {'briefSummary': 'Hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. Situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. Hypophosphatemia in this context is attributed to an excess of FGF-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate.\n\nRendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subject (≥ 18 years old) suffering from Rendu-Osler disease and receiving IV iron supplementation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subject (≥ 18 years old)\n* suffering from Rendu-Osler disease and receiving IV iron supplementation\n* Subject not objecting, after information, to the reuse of their data for scientific research purposes\n\nExclusion criteria:\n\n* Subject who expressed their opposition to participating in the study\n* Subject under safeguard of justice\n* Subject under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT05544669', 'acronym': 'OS-LERETRO', 'briefTitle': 'Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease', 'orgStudyIdInfo': {'id': '8696'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Murielle RONDEAU-LUTZ, MD', 'role': 'CONTACT', 'email': 'murielle.rondeau-lutz@chru-strasbourg.fr', 'phone': '33 3 69 55 10 13'}, {'name': 'Massimo RONDEAU-LUTZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc LAPLACE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier VOLLMER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rose-Marie JAVIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe MERTZ, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Médecine interne - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Murielle RONDEAU-LUTZ, MD', 'role': 'CONTACT', 'email': 'murielle.rondeau-lutz@chru-strasbourg.fr', 'phone': '33 3 69 55 10 13'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}