Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-02 @ 3:26 AM
Study NCT ID:
NCT04821492
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Homocysteine and BMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMD expressed in absolute values as g/cm2', 'timeFrame': 'one year before or after Homocysteine levels'}, {'measure': 'Lumbar spine T-score', 'timeFrame': 'one year before or after Homocysteine levels'}, {'measure': 'Femoral neck T-score', 'timeFrame': 'one year before or after Homocysteine levels'}, {'measure': 'Total hip T-score', 'timeFrame': 'one year before or after Homocysteine levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Women']}, 'referencesModule': {'references': [{'pmid': '18289506', 'type': 'BACKGROUND', 'citation': 'Cagnacci A, Bagni B, Zini A, Cannoletta M, Generali M, Volpe A. Relation of folates, vitamin B12 and homocysteine to vertebral bone mineral density change in postmenopausal women. A five-year longitudinal evaluation. Bone. 2008 Feb;42(2):314-20. doi: 10.1016/j.bone.2007.10.022. Epub 2007 Nov 12.'}, {'pmid': '29911042', 'type': 'BACKGROUND', 'citation': 'Mittal M, Verma R, Mishra A, Singh A, Kumar V, Sawlani KK, Ahmad MK, Mishra P, Gaur R. Relation of Bone Mineral Density with Homocysteine and Cathepsin K levels in Postmenopausal Women. Indian J Endocrinol Metab. 2018 Mar-Apr;22(2):261-266. doi: 10.4103/ijem.IJEM_575_17.'}, {'pmid': '24631997', 'type': 'BACKGROUND', 'citation': 'Enneman AW, Swart KM, Zillikens MC, van Dijk SC, van Wijngaarden JP, Brouwer-Brolsma EM, Dhonukshe-Rutten RA, Hofman A, Rivadeneira F, van der Cammen TJ, Lips P, de Groot CP, Uitterlinden AG, van Meurs JB, van Schoor NM, van der Velde N. The association between plasma homocysteine levels and bone quality and bone mineral density parameters in older persons. Bone. 2014 Jun;63:141-6. doi: 10.1016/j.bone.2014.03.002. Epub 2014 Mar 12.'}, {'pmid': '26922199', 'type': 'BACKGROUND', 'citation': 'Bahtiri E, Islami H, Rexhepi S, Qorraj-Bytyqi H, Thaci K, Thaci S, Karakulak C, Hoxha R. Relationship of homocysteine levels with lumbar spine and femur neck BMD in postmenopausal women. Acta Reumatol Port. 2015 Oct-Dec;40(4):355-62.'}], 'seeAlsoLinks': [{'url': 'http://dexeus.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women visited at the Obstetrics and Gynecology Department at the Hospital Universitario Dexeus (Barcelona, Spain).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women\n* BMD measured by dual-energy X-ray absorptiometry (DXA)\n\nExclusion Criteria:\n\n* Primary ovarian failure\n* Early menopause\n* Cardiovascular, liver, or renal diseases\n* Surgical menopause\n* History of cancer\n* Receiving treatment known to influence levels of Hcy or bone mineralization (folates or vitamin B12 supplements, menopausal hormonal treatment, corticosteroids, anticonvulsants, heparin, thiazide diuretics, and antiresorptive agents).'}, 'identificationModule': {'nctId': 'NCT04821492', 'briefTitle': 'Relationship Between Homocysteine and BMD', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'FSD-HCY-2020-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hyperhomocysteinemia', 'interventionNames': ['Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)']}, {'label': 'Normal Hcy levels', 'interventionNames': ['Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)']}], 'interventions': [{'name': 'Dual-Energy X-ray Absorptiometry (DXA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'BMD expressed in absolute values as g/cm2 and T-scores', 'armGroupLabels': ['Hyperhomocysteinemia', 'Normal Hcy levels']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Quiron Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Santiago Dexeus Font', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pascual García', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}