Clinical trial NCT05303350: Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoporosis
Fracture
Keywords: Osteoporosis
Fracture
Fracture liaison service
Digital medicine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French Society of Rheumatology
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \> 60 years with recent fracture (less of 3 months) included in existing FLS in France

Brief 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: one year
Secondary outcomes:
measure: To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs
timeFrame: one year
measure: To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS
timeFrame: one year
measure: To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS
timeFrame: one year
measure: To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital, Rheumatology Department
Study officials:
affiliation: APHP
name: Karine BRIOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: