Drug Interactions and Hip Fracture Risk in Older Adults | NCT04731597

Studies
Drug Interactions and Hip Fracture Risk in Older Adults

NCT04731597

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Feb 2, 2021Actual

Enrollment

9,721Actual

Phase

Not provided

Conditions

Hip Fractures

Interventions

drug interaction

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2018Actual

Primary Completion Date

Nov 25, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Jan 26, 2021

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Feb 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

CRISTINA MARIA ELIZONDO, Principal Investigator, Hospital Italiano de Buenos AiresPrincipal Investigator

Lead Sponsor

Hospital Italiano de Buenos AiresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,721Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
drug interaction	Drug	when two drugs are taken together	Cases with hip fracture controls without hip fracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hip fracture	non pathological hip fracture	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

64 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires		CABA	Buenos Aires	1199	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 15, 2022
Reset	Apr 18, 2022
Release	May 1, 2023
Reset	Jan 23, 2024

Submission Tracking

Estimated Results First Submitted Date

Feb 15, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 15, 2022			Apr 18, 2022
May 1, 2023

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004347	Drug Interactions

Ancestor Terms

ID	Term
D000069437	Pharmacological Phenomena
D002620	Pharmacological and Toxicological Phenomena
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided