HypertensionFADINCT06964217
Immediate Fracture Risk After Antihypertensive Drug Initiation
An observational study of Hypertension and Fracture, run by Ajou University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Hypertension, Fracture
- What is being tested?
- Monotherapy and Combination therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 10,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Overall Fracture Risk Immediately After Anti-hypertensive Medication Initiation and Temporal Trend in Initial Pharmacotherapy Regimens: An Observational Study
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.
- Conditions
- Hypertension, Fracture
- Being tested
- Monotherapy, Combination therapy
- Medical subject headings
- Hypertension, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonotherapyDrug
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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | 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. Receives: Drug: Monotherapy | |
| Combination therapy | 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. Receives: Drug: Combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall fracture risk
First incidence of non-traumatic fracture in either proximal humerus, distal radius/ulna, thoraco-lumbar vertebrae, sacrum/pelvis, or proximal hip
Measured: 45 days after initiation of antihypertensive medication
Secondary outcomes (1)
Hip fracture
First incidence of non-traumatic proximal hip fracture
Measured: 45 days after initiation of antihypertensive medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion28 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Min Lee, Ajou University School of Medicine
- Investigators
- Rae Woong Park, M.D., Ph.D., Principal investigator, Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964217
- Sponsor's protocol ID
- AJOUIRB-EX-2025-198
- Acronym
- FADI
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 23165923Dave 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.
PubMed 38648065
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Fracture Risk Immediately After Anti-hypertensive Medication Initiation and Temporal Trend in Initial Pharmacotherapy Regimens: An Observational Study
- ClinicalTrials.gov ID
- NCT06964217
- Acronym / sponsor ID
- FADI / AJOUIRB-EX-2025-198
- Conditions
- Hypertension, Fracture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000,000 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | – | Drug: MonotherapyCommunity-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. |
| Combination therapy | – | Drug: Combination therapyCommunity-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. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonotherapyAntihypertensive 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. | Drug | Monotherapy |
| Combination therapyAntihypertensive 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. | Drug | Combination therapy |
Primary outcome
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
1 secondary outcome
Hip fracture
Time frame: 45 days after initiation of antihypertensive medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 23165923Butt 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.
- Background: PubMed 38648065Dave 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rae Woong Park, M.D., Ph.D. principal investigator
Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Fracture, run by Ajou University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong Min Lee, M.D. (+82-10-5443-3196, jongmin.lee.35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall fracture risk (time frame: 45 days after initiation of antihypertensive medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964217, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.