Longitudinal Evaluation of a Fracture Liaison Service | NCT06847776

Studies
Longitudinal Evaluation of a Fracture Liaison Service

NCT06847776

Sponsor

Central Hospital, Nancy, France

Status

Enrolling by invitation

Last Update Posted

Feb 26, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Osteoporosis

Interventions

Not provided

Countries

France

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2025Actual

Primary Completion Date

Jan 2, 2030Estimated

Completion Date

Jan 2, 2030Estimated

First Submitted Date

Feb 7, 2025

First Submission Date that Met QC Criteria

Feb 21, 2025

First Posted Date

Feb 26, 2025Actual

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

Feb 21, 2025

Last Update Posted Date

Feb 26, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The major objective of this study is to evaluated osteoporosis prevalence, both on computed tomography (CT) and dual x ray absorptiometry (DXA) in patients included in a fracture liaison service (FLS).

The secondary objectives are to evaluate the prevalence of antiosteoporotic treatments indication, of new fractures or mortality; to identify the risk factor for osteoporosis; the study the treatment's observance; to identify the screening threshold to diagnose osteoporosis on CT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Osteoporosis prevalence on DXA and CT		during the evaluation in the fracture liaison service FLS and evry year until 5 years

Secondary Outcomes

Measure	Description	Time Frame
prevalnce of treatment for osteoporosis		during the evaluation in FLS and every year until 5 years
prevalence of new fractures at 1-3 and 5 years		during the evaluation in FLS and at 1, 3 and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >= 50 years
Bone fracture due to a fall

Exclusion Criteria:

patient's opposition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients included in the fracture liaison service

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy		Vandœuvre-lès-Nancy		54500	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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
D050723	Fractures, Bone

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