[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590192":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":10,"responsibleParty":38,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":10,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Ajou University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy",null,"Community-dwelling patients who get prescription of per oral anti-hypertensive drug (AHD) at an outpatient visit for hypertension diagnosis, without an exposure to any antihypertensive medication in the preceding year.",[13],"Drug: Monotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Combination therapy","Community-dwelling patients who get prescription of per oral antihypertensive pill\u002Fpills with two or more drug classes of AHDs - on a same day at an outpatient visit for hypertension diagnosis, without an exposure to any antihypertensive medication in the preceding year.",[18],"Drug: Combination therapy",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Antihypertensive medications, regardless of dose or formulation, will be classified by their pharmacologic class. A total of eight drug classes will be considered: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, dihydropyridine calcium channel blockers (DHP-CCBs), non-dihydropyridine calcium channel blockers (non-DHP-CCBs), loop diuretics, thiazide and thiazide-like diuretics, and potassium-sparing diuretics.\n\nExposure groups will be defined as follows:\n\n* Monotherapy: prescription of a single antihypertensive drug class on the index date.\n* Dual therapy: prescription of two ore more antihypertensive drug classes on the same index date.\n\nTo qualify for group assignment, all drugs must be initiated on the same day, and the drug of interest is limited to the class described in group\u002Fcohort.\n\nOut of the two, this intervention will be monotherapy.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":10},"Antihypertensive medications, regardless of dose or formulation, will be classified by their pharmacologic class. A total of eight drug classes will be considered: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, dihydropyridine calcium channel blockers (DHP-CCBs), non-dihydropyridine calcium channel blockers (non-DHP-CCBs), loop diuretics, thiazide and thiazide-like diuretics, and potassium-sparing diuretics.\n\nExposure groups will be defined as follows:\n\n* Monotherapy: prescription of a single antihypertensive drug class on the index date.\n* Dual therapy: prescription of two or more antihypertensive drug classes on the same index date.\n\nTo qualify for group assignment, all drugs must be initiated on the same day, and the drug of interest is limited to the class described in group\u002Fcohort.\n\nOut of the two, this intervention will be combination therapy.",[15],[28],{"name":29,"affiliation":30,"role":31},"Rae Woong Park, M.D., Ph.D.","Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Jong Min Lee, M.D.","CONTACT","+82-10-5443-3196","jongmin.lee.35@gmail.com",{"type":31,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jong Min Lee","Teaching Assistant (M.D)","100590192","immediate-fracture-risk-after-antihypertensive-drug-initiation-100590192",false,"NCT06964217","Immediate Fracture Risk After Antihypertensive Drug Initiation","Overall Fracture Risk Immediately After Anti-hypertensive Medication Initiation and Temporal Trend in Initial Pharmacotherapy Regimens: An Observational Study","FADI","Inclusion Criteria:\n\n* Individuals with at least 365 days of continuous observation prior to the index date (defined as the date of first antihypertensive medication prescription), with no prior antihypertensive use during that period\n* At least one diagnosis of hypertension (ICD-10 codes I10-I13, I15) recorded within 180 days before the index date\n\nExclusion Criteria (main cohort):\n\n* Any of the following occurring in the 365 days prior to the index date: Hospitalization (inpatient admission, including long-term care facility), transport-related trauma (ICD-10 codes V01-V99), Intentional self-harm (ICD-10 codes X60-X84, Y87), History of pathological fractures (e.g., M84.4, M90.7), Evidence of end-stage renal disease (ESRD), dialysis, kidney transplant, renal osteodystrophy","ALL","50 Years","100 Years",{"count":53,"type":54},10000000,"ESTIMATED","OBSERVATIONAL","This retrospective observational study aims to evaluate the short-term fracture risk associated with anti-hypertensive medication initiation using a self-controlled case series (SCCS) design and investigate temporal trends of initial anti-hypertensive regimen (monotherapy vs combination therapy) and subsequent fracture incidence. The investigators use the Korean Health Insurance Review and Assessment (HIRA) database to identify adults aged ≥65 with a new prescription for anti-hypertensive therapy and at least one incident non-traumatic fracture.\n\nIn the SCCS analysis, the investigators estimate the within-person incidence rate of overall fractures during the 30-day period following anti-hypertensive initiation compared to control periods. Temporal trends will be recorded through 2013 - 2022.\n\nThe primary outcome is overall non-traumatic fracture occurrence; the secondary outcome is incident proximal hip fracture. These outcomes are defined using diagnostic and procedural codes validated for use in claims data. This study aims to quantify both the immediate temporal association between treatment initiation and fracture risk, and the comparative safety of different initial anti-hypertensive regimens.",[58,59],"Hypertension","Fracture","NOT_YET_RECRUITING","2025-05-22",{"date":63,"type":64},"2025-05-28","ACTUAL",{"date":66,"type":54},"2025-06-01",{"date":68,"type":54},"2025-07-31",{"name":5,"class":6}]