Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)

Osteoporosis Clinical Trial

— evAB  

Official title:

Multicentric Study of Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05303350
• Other study ID #: APHP211339
• Secondary ID: 2022-A00553-40
• Status: Withdrawn
• Start date: February 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.

Description:

Osteoporotic fractures such as hip fractures and severe fractures are associated with increased morbidity and mortality and impose a large financial burden on healthcare systems. Patients with osteoporosis-related fractures are at higher risk of subsequent fractures. Other severe fractures (pelvis, vertebrae, humerus) have similar consequences, pelvis. The risk of refracture after fracture depends on the time: it is 5 times higher in the first 2-3 years, and 2 times higher after. This notion of Imminent Fracture Risk is the basis for the development of post-fracture care pathways called "fracture liaison. The implementation of FLS is the most effective way to reduce the risk of secondary fracture. Despite their success, FLS programs are not an integral part of post-fracture care throughout the France. The investigators believe that the barriers to the implementation of such a pathway are multiple and are largely related to the lack of accessibility for patients to FLS, and to the mobilization of important and unsustainable human resources. Some French public hospitals or institutions are currently building some e_FLS models based on an automatic detection of patients with fractures, and a on a cloud-based system where practitioners across the health care sector can communicate and jointly manage osteoporotic patients. The investigators' hypothesis is that this web FLS (e_FLS) is at least as effective as the classical FLS for the secondary fracture prevention.

The objective of the investigators' study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture (evAB project).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged above 60 years, living in France, with fragility fractures in response to low-energy trauma (e.g., a fall from standing height).

• The patient or his legal representative does not object to the patient's participation in the research Note: Patients in guardianship or curatorship can be included in this protocol

Exclusion Criteria:

• Pathological fractures, high trauma fractures and per prosthetic fractures.

• Non registration with a social security scheme (holder or beneficiary).

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Osteoporosis

Locations

Country	Name	City	State
France	Cochin Hospital, Rheumatology Department	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	French Society of Rheumatology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of eFLS to conventional FLS to initiate an antiosteoporotic treatment after a recent fracture (<3 months) at one year in patients aged 60 years and more	Number of patients receiving an antiosteoporotic treatment at one year	one year
Secondary	To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs	Number of patients seen in the FLS	one year
Secondary	To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS	Incident fracture rate over 1 year	one year
Secondary	To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS	Mortality rate over 1 year	one year
Secondary	To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS	Bone densitometry at 1 year	one year