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

NCT05303350 | Withdrawn

• 2 other identifiers: APHP2113392022-A00553-40
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fracture

Keywords

Osteoporosis; Fracture; Fracture liaison service; Digital medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs

  one year

• To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS

  one year

• To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS

  one year

• To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS

  one year

Study Arms (2)

e_FLS

Patients detected by an automated patient detection tool with a web-based platform

FLS

Control group / Conventional group : Patients followed in a conventional fracture liaison department

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \> 60 years with recent fracture (less of 3 months) included in existing FLS in France

You may qualify if:

• 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

You may not qualify if:

• Pathological fractures, high trauma fractures and per prosthetic fractures.
• Non registration with a social security scheme (holder or beneficiary).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• French Society of Rheumatology: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital, Rheumatology Department

Paris, 75014, France

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Karine BRIOT, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)