Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-02-06 @ 2:03 AM
Study NCT ID:
NCT01778361
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, buffy coat, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-01-25', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fracture incidence', 'timeFrame': '3 years', 'description': 'To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.'}], 'primaryOutcomes': [{'measure': 'Bone pathology', 'timeFrame': '3 years', 'description': 'To describe abnormalities in bone pathology in bone biopsies from HIV-infected subjects with low bone mineral density by comparing biopsy indices to reference ranges.'}], 'secondaryOutcomes': [{'measure': 'Rates of change in bone mineral density', 'timeFrame': '3 years', 'description': 'To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human immunodeficiency virus', 'low bone mineral density', 'osteopenia', 'osteoporosis', 'fracture'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.', 'detailedDescription': 'This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include:\n\n* to describe the pathology underlying low bone mineral density\n* to assess the relationship between low bone mineral density and antiretroviral therapy exposure\n* to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism\n* to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism\n* to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV positive patients and HIV negative subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* be able to provide written, informed consent\n* be able to attend the research centre in a fasting state and undergo DEXA scanning\n\nExclusion Criteria:\n\n* Subjects on bisphosphonate therapy at screening\n* Pregnant or breastfeeding female subjects\n* Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening\n* HIV-negative subjects with a prior history of osteoporosis'}, 'identificationModule': {'nctId': 'NCT01778361', 'acronym': 'UPBEAT', 'briefTitle': 'HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University College Dublin'}, 'officialTitle': 'HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected. A Prospective Cohort Study of HIV-infected Patients and HIV-negative Subjects.', 'orgStudyIdInfo': {'id': 'HIVUPBEAT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV positive'}, {'label': 'HIV negative'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D 7', 'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Tara n McGinty, MB BAO BCh', 'role': 'CONTACT', 'email': 'tara.mcginty@ucd.ie'}, {'name': 'Patrick WG Mallon, MB BCh, PhD, FRCPI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gerard Sheehan, MB BCh BAO, FRCPI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Lambert, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'Tara N mcGinty, MB BCh BAO', 'role': 'CONTACT', 'email': 'tara.mcginty@ucd.ie'}, {'name': 'Babu Sumesh', 'role': 'CONTACT', 'email': 'sumesh.babu@ucd.ie'}], 'overallOfficials': [{'name': 'Patrick WG Mallon, MB BCh, BSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIV Molecular Research Group, University College Dublin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Dublin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Research Board, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean of Post-graduate Research, School of Medicine and Medical Sciences, Head of HIV Molecular Research Group, Consultant Infectious Diseases.', 'investigatorFullName': 'Patrick Mallon', 'investigatorAffiliation': 'University College Dublin'}}}}