OsteoporosisevABNCT05303350
Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)
An observational study of Osteoporosis and Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2024to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged > 60 years with recent fracture (less of 3 months) included in existing FLS in France
Who may be able to join
- 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
Who cannot join
- Pathological fractures, high trauma fractures and per prosthetic fractures.
- Non registration with a social security scheme (holder or beneficiary).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Osteoporosis, Fracture
- Keywords
- Osteoporosis, Fracture, Fracture liaison service, Digital medicine
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (4)
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
Measured: one year
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
Measured: one year
To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS
Mortality rate over 1 year
Measured: one year
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: logistic difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Rheumatology, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Karine BRIOT, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303350
- Sponsor's protocol ID
- APHP211339
- Other IDs
- 2022-A00553-40
- Acronym
- evAB
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05303350
- Acronym / sponsor ID
- evAB / APHP211339
- Conditions
- Osteoporosis, Fracture
- Keywords
- Osteoporosis, Fracture, Fracture liaison service, Digital medicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: logistic difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- French Society of Rheumatology, URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 60 years with recent fracture (less of 3 months) included in existing FLS in France
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pathological fractures, high trauma fractures and per prosthetic fractures.
- Non registration with a social security scheme (holder or beneficiary).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: one year
Number of patients receiving an antiosteoporotic treatment at one year
4 secondary outcomes
To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs
Time frame: one year
To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS
Time frame: one year
To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS
Time frame: one year
To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine BRIOT, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.