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Not yet recruiting NCT06964217

Immediate Fracture Risk After Antihypertensive Drug Initiation

— Observational Hypertension Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monotherapy, Combination therapy.
Who it may be relevant to
Registry conditions: Hypertension, Fracture. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Overall Fracture Risk Immediately After Anti-hypertensive Medication Initiation and Temporal Trend in Initial Pharmacotherapy Regimens: An Observational Study

Overview

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.

Interventions

  • Drug 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 define
  • 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 define

Primary outcome measures

  • Overall fracture risk [Time frame: 45 days after initiation of antihypertensive medication]
Secondary outcome measures (1)
  • Hip fracture [Time frame: 45 days after initiation of antihypertensive medication]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion Criteria (main cohort):

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Butt DA, Mamdani M, Austin PC, Tu K, Gomes T, Glazier RH. The risk of hip fracture after initiating antihypertensive drugs in the elderly. Arch Intern Med. 2012 Dec 10;172(22):1739-44. doi: 10.1001/2013.jamainternmed.469. PMID 23165923
  • Dave CV, Li Y, Steinman MA, Lee SJ, Liu X, Jing B, Graham LA, Marcum ZA, Fung KZ, Odden MC. Antihypertensive Medication and Fracture Risk in Older Veterans Health Administration Nursing Home Residents. JAMA Intern Med. 2024 Jun 1;184(6):661-669. doi: 10.1001/jamainternmed.2024.0507. PMID 38648065

Identifiers

NCT: NCT06964217 · AJOUIRB-EX-2025-198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗