Risk of Osteoporotic Fracture in Home Care Patients in Tu... | NCT05738785

Studies
Risk of Osteoporotic Fracture in Home Care Patients in Turkey

NCT05738785

Sponsor

Uskudar State Hospital

Status

Unknown status

Last Update Posted

May 23, 2023Actual

Enrollment

370Estimated

Phase

Not provided

Conditions

Osteoporosis
Osteoporosis Risk
Osteoporotic Fractures

Interventions

Document review and scanning

Countries

Turkey (Türkiye)

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Estimated

Primary Completion Date

Dec 13, 2023Estimated

Completion Date

Jun 13, 2024Estimated

First Submitted Date

Feb 12, 2023

First Submission Date that Met QC Criteria

Feb 12, 2023

First Posted Date

Feb 22, 2023Actual

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

May 20, 2023

Last Update Posted Date

May 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Hüseyin Temel, Uzm. Dr. Mustafa Hüseyin Temel, Uskudar State HospitalPrincipal Investigator

Lead Sponsor

Uskudar State HospitalOTHER_GOV

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

This study will assess the incidence of osteoporosis and osteoporotic fracture risk of registered home health patients in the Anatolian side of Istanbul.

Detailed Description

After selecting the patients who have been visited by the team in the last 6 months from the patients registered in the home health system, the number of patients required to reflect the population will be determined, and patient files will be selected by randomization. Demographic information, comorbidities, medications, and blood tests will be recorded. FRAX risks of the patients will be calculated, and it will be examined whether they have any previous fracture history and whether they have received treatment for osteoporosis.

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

370Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home health care patients		Home health patients registered in the Anatolian side of Istanbul	Other: Document review and scanning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Document review and scanning	Other	Osteoporosis risk and osteoporotic fracture risk will be calculated by examining the patients' files.	Home health care patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Osteoporotic fracture risk of home care patients	Osteoporotic fracture risk of home care patients	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being registered for home health services Having made a call to home health services in the last 6 months

Exclusion Criteria:

Patients that have passed away

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Home care patients who have called home health services in the last 6 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mustafa H Temel, M.D.	Contact	+905342714872		mhuseyintemel@gmail.com
Fatih Bağcıer, M.D.	Contact	+905442429042		bagcier_42@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Üsküdar State Hospital		Istanbul	Üsküdar		Turkey (Türkiye)

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

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D058866	Osteoporotic Fractures

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided