Hip FracturesNCT04731597
Drug Interactions and Hip Fracture Risk in Older Adults
An observational study of Hip Fractures, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Older people are in great risk of hip fracture for multiple reasons. Also they often are on medications for medical conditions. Hip fracture risk increases in relation to some medications. When older peoples take 2 or more medications they are in increase risk of hip fracture. Read more about this study
- Who is it for?
- Ages 64 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- drug interaction
- How many people
- 9,721 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Aug 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 64 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cases: * Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated. * older than 64 years old. affiliated between 01/07/2014 al 31/12/2019. * traumatic hip fracture. controls: * Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated. * older than 64 years old. * affiliated between 01/07/2014 al 31/12/2019. * without traumatic hip fracture.
Who may be able to join
- Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated.
- older than 64 years old
- affiliated between 01/07/2014 al 31/12/2019.
Who cannot join
- Pathological Hip fracture
- bilateral elective hip replacement previous study period
Trial locations and contacts
1 site in 1 country.
About this study
Older people are in great risk of hip fracture for multiple reasons. Also they often are on medications for medical conditions. Hip fracture risk increases in relation to some medications. When older peoples take 2 or more medications they are in increase risk of hip fracture.
Read the detailed description
In this study the investigators describe medication intake profile and identify older people risk of hip fracture in relation to their medication when they are taken together.
- Conditions
- Hip Fractures
- Being tested
- drug interaction
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug interactionDrug
when two drugs are taken together
| Study group | Role | What they receive |
|---|---|---|
| Cases with hip fracture | Patients afiliated to a HMO Plan de Salud Hospital Italiano who presented hip fracture between 2014 and 2019 Receives: Drug: drug interaction | |
| controls without hip fracture | Patients afiliated to a HMO Plan de Salud Hospital Italiano without hip fracture between 2014 and 2019 Receives: Drug: drug interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip fracture
non pathological hip fracture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start16 Aug 2018
- Primary completion25 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA MARIA ELIZONDO, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731597
- Sponsor's protocol ID
- 3804
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interactions and Hip Fracture Risk in Older Adults
- ClinicalTrials.gov ID
- NCT04731597
- Acronym / sponsor ID
- 3804
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,721 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Feb 2021 (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.
Older people are in great risk of hip fracture for multiple reasons. Also they often are on medications for medical conditions. Hip fracture risk increases in relation to some medications. When older peoples take 2 or more medications they are in increase risk of hip fracture.
Detailed description
In this study the investigators describe medication intake profile and identify older people risk of hip fracture in relation to their medication when they are taken together.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with hip fracture | – | Drug: drug interactionPatients afiliated to a HMO Plan de Salud Hospital Italiano who presented hip fracture between 2014 and 2019 |
| controls without hip fracture | – | Drug: drug interactionPatients afiliated to a HMO Plan de Salud Hospital Italiano without hip fracture between 2014 and 2019 |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cases: * Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated. * older than 64 years old. affiliated between 01/07/2014 al 31/12/2019. * traumatic hip fracture. controls: * Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated. * older than 64 years old. * affiliated between 01/07/2014 al 31/12/2019. * without traumatic hip fracture.
Key inclusion criteria (3 listed)
- Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated.
- older than 64 years old
- affiliated between 01/07/2014 al 31/12/2019.
Key exclusion criteria (2 listed)
- Pathological Hip fracture
- bilateral elective hip replacement previous study period
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 |
|---|---|---|
| drug interactionwhen two drugs are taken together | Drug | Cases with hip fracture, controls without hip fracture |
Primary outcome
hip fracture
Time frame: 1 year
non pathological hip fracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip fracture (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.