- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04731597
Drug Interactions and Hip Fracture Risk in Older Adults
January 29, 2021 updated by: CRISTINA MARIA ELIZONDO, Hospital Italiano de Buenos Aires
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
9721
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Buenos Aires
-
Caba, Buenos Aires, Argentina, 1199
- Hospital Italiano de Buenos Aires
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
64 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
* 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.
Exclusion Criteria:
- Pathological Hip fracture
- bilateral elective hip replacement previous study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases with hip fracture
Patients afiliated to a HMO Plan de Salud Hospital Italiano who presented hip fracture between 2014 and 2019
|
when two drugs are taken together
|
controls without hip fracture
Patients afiliated to a HMO Plan de Salud Hospital Italiano without hip fracture between 2014 and 2019
|
when two drugs are taken together
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hip fracture
Time Frame: 1 year
|
non pathological hip fracture
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2018
Primary Completion (Actual)
November 25, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (Actual)
February 1, 2021
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 29, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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