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NCT Number: NCT06964217

Immediate Fracture Risk After Antihypertensive Drug Initiation

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Fracture Fractures, Bone Vascular Diseases Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

Overall fracture risk

Time frame: 45 days after initiation of antihypertensive medication

First incidence of non-traumatic fracture in either proximal humerus, distal radius/ulna, thoraco-lumbar vertebrae, sacrum/pelvis, or proximal hip

Secondary outcomes

Hip fracture

Time frame: 45 days after initiation of antihypertensive medication

First incidence of non-traumatic proximal hip fracture

Study contacts

Contact information is provided by the study sponsor or research team.

Jong Min Lee, M.D.

CONTACT

[email protected]

+82-10-5443-3196

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Acronym: FADI

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 9, 2025
Registry last updated: May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed