NCT06964217Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10000000 (estimated)
- First submitted
- 1 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- Ajou University School of Medicine
- Diseases
- High blood pressure
- NCT number
- NCT06964217
What you commit to
- Study type: Observational
- Planned participants: 10000000
- From 1 Jun 2025 to the primary completion date, 28 Jul 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.