NCT04731597

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,721

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

January 26, 2021

Last Update Submit

January 29, 2021

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • hip fracture

    non pathological hip fracture

    1 year

Study Arms (2)

Cases with hip fracture

Patients afiliated to a HMO Plan de Salud Hospital Italiano who presented hip fracture between 2014 and 2019

Drug: drug interaction

controls without hip fracture

Patients afiliated to a HMO Plan de Salud Hospital Italiano without hip fracture between 2014 and 2019

Drug: drug interaction

Interventions

drug interactionDRUG

when two drugs are taken together

Cases with hip fracturecontrols without hip fracture

Eligibility Criteria

Age64 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \* 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.

You may not qualify if:

  • Pathological Hip fracture
  • bilateral elective hip replacement previous study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, 1199, Argentina

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

August 16, 2018

Primary Completion

November 25, 2020

Study Completion

December 30, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)