NCT06847776

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress28%
Jan 2025Jan 2030

Study Start

First participant enrolled

January 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2030

Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

5 years

First QC Date

February 7, 2025

Last Update Submit

February 21, 2025

Conditions

Osteoporosis

Keywords

osteoporosisfracturesDXACT

Outcome Measures

Primary Outcomes (1)

  • Osteoporosis prevalence on DXA and CT

    during the evaluation in the fracture liaison service FLS and evry year until 5 years

Secondary Outcomes (8)

  • 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

  • identification of osteoporosis risk factors

    at the inclusion in FLS

  • definition of the CT threshold for bone fragility in this population;

    at the inclusion in FLS

  • study of the correlation dual x ray absorptiometry and computed tomography bone fragility evaluation

    at the inclusion in FLS

  • +3 more secondary outcomes

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients included in the fracture liaison service

You may qualify if:

  • age \>= 50 years
  • Bone fracture due to a fall

You may not qualify if:

  • patient's opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

OsteoporosisFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 26, 2025

Study Start

January 2, 2025

Primary Completion (Estimated)

January 2, 2030

Study Completion (Estimated)

January 2, 2030

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations

FR(1)