Immediate Fracture Risk After Antihypertensive Drug Initiation

ConditionsHypertension Fracture

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50-100

SponsorAjou University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

At least one diagnosis of hypertension (ICD-10 codes I10-I13, I15) recorded within 180 days before the index date

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Monotherapy
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. 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.
Combination therapy
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. 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.

Treatment groups

10,000,000 Participants

are divided into 2 treatment groups

Group A: Monotherapy1 intervention

Group B: Combination therapy1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

Hip fracture

First incidence of non-traumatic proximal hip fracture

Time frame

45 days after initiation of antihypertensive medication

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ajou University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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