Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 1:25 PM
Study NCT ID:
NCT01968850
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage changes in BMD at a) the lumbar spine and b) proximal femur', 'timeFrame': '48 weeks', 'description': 'The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.'}], 'secondaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '48 weeks', 'description': 'The proportion of patients who are eligible and who consent to participate will be calculated, and the timeliness (rate) of enrollment will be described, to further inform the feasibility of a larger randomized controlled trial.'}, {'measure': 'Acceptability', 'timeFrame': '48 weeks', 'description': 'Using standardized questions, participants will be asked about the acceptability of the alendronate therapy (including the experience of pill-taking and the weekly schedule)'}, {'measure': 'Safety/Tolerability', 'timeFrame': '48 weeks', 'description': 'As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.'}, {'measure': 'Adherence', 'timeFrame': '48 weeks', 'description': 'Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.'}, {'measure': 'Bone Biomarkers', 'timeFrame': '48 weeks', 'description': 'Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoporosis', 'HIV', 'bone Mineral Density', 'alendronate', 'vitamin D'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:\n\n1. no bone anti-resorptive therapy (standard of care)\n2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;\n3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D\n\nAssessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented HIV-1 infection\n* Adult (aged \\>18 years or as per local guidelines)\n* Premenopausal, if female\n* Antiretroviral-naïve\n* Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)\n* Low (\\<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations\n\nExclusion Criteria:\n\n* Presence of established osteoporosis at baseline as determined by BMD measurement\n* Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)\n* Inability to communicate in English\n* Creatinine clearance \\<35 mL/min (using Cockcroft-Gault formula)\n* Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation\n* Hypocalcemia\n* Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia\n* Inability to stand or sit upright for at least 30 minutes\n* Pregnancy, active plans to become pregnant, or lactation'}, 'identificationModule': {'nctId': 'NCT01968850', 'acronym': 'BATARI', 'briefTitle': 'Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial', 'orgStudyIdInfo': {'id': 'CTNPT 021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no bone anti-resorptive therapy', 'description': '(standard of care)'}, {'type': 'EXPERIMENTAL', 'label': '24-week tx of alendronate/vitamin D', 'description': 'Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D', 'interventionNames': ['Drug: alendronate/vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed 24-week tx of alendronate/vitamin D', 'description': 'a 24 week delay in initiation of a 24 week course of alendronate/vitamin D', 'interventionNames': ['Drug: alendronate/vitamin D']}], 'interventions': [{'name': 'alendronate/vitamin D', 'type': 'DRUG', 'otherNames': ['Fosavance 70/56'], 'description': 'once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.', 'armGroupLabels': ['24-week tx of alendronate/vitamin D', 'Delayed 24-week tx of alendronate/vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Darrell Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'CIHR Canadian HIV Trials Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}