An observational study in Hypertension and Fracture, sponsored by Ajou University School of Medicine. Not yet recruiting. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Ajou University School of Medicine · 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.
In 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.
The 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 10,000,000 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community-dwelling patients who are new users of antihypertensive medication, defined as individuals with no prior antihypertensive exposure in the 365 days prior to the index date
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria (main cohort):
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.
Drug: Monotherapy
Community-dwelling patients who get prescription of per oral antihypertensive pill/pills 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.
Drug: Combination therapy
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. Exposure groups will be defined as follows: * Monotherapy: prescription of a single antihypertensive drug class on the index date. * Dual therapy: prescription of two ore more antihypertensive drug classes on the same index date. To 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/cohort. Out of the two, this intervention will be monotherapy.
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. Exposure groups will be defined as follows: * Monotherapy: prescription of a single antihypertensive drug class on the index date. * Dual therapy: prescription of two or more antihypertensive drug classes on the same index date. To 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/cohort. Out of the two, this intervention will be combination therapy.
Overall fracture risk
First incidence of non-traumatic fracture in either proximal humerus, distal radius/ulna, thoraco-lumbar vertebrae, sacrum/pelvis, or proximal hip
Time frame: 45 days after initiation of antihypertensive medication
Hip fracture
First incidence of non-traumatic proximal hip fracture
Time frame: 45 days after initiation of antihypertensive medication
No study locations are listed for this record.
Plan to share: No — This study uses de-identified secondary data from the Korean Health Insurance Review and Assessment (HIRA) database. Individual-level data cannot be shared publicly due to legal and privacy restrictions.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ajou University School of Medicine →