OsteoporosisFILFRANCT06847776
Longitudinal Evaluation of a Fracture Liaison Service
An observational study of Osteoporosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 2 Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients included in the fracture liaison service
Who may be able to join
- age >= 50 years
- Bone fracture due to a fall
Who cannot join
- patient's opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, fractures, DXA, CT
- Medical subject headings
- Osteoporosis, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis prevalence on DXA and CT
Measured: during the evaluation in the fracture liaison service FLS and evry year until 5 years
Secondary outcomes (8)
prevalnce of treatment for osteoporosis
Measured: during the evaluation in FLS and every year until 5 years
prevalence of new fractures at 1-3 and 5 years
Measured: during the evaluation in FLS and at 1, 3 and 5 years
identification of osteoporosis risk factors
Measured: at the inclusion in FLS
definition of the CT threshold for bone fragility in this population;
Measured: at the inclusion in FLS
study of the correlation dual x ray absorptiometry and computed tomography bone fragility evaluation
Measured: at the inclusion in FLS
study of the correlation between FRAX score and DXA
Measured: at the inclusion in FLS
study of the correlation between FRAX score and Trabecular bone score TBS
Measured: at the inclusion in FLS
study of the correlation between FRAX score and lean mass
Measured: at the inclusion in FLS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start2 Jan 2025
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jan 2030 (estimated)
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 Central Hospital, Nancy, FranceThe 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marine FAUNY, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847776
- Sponsor's protocol ID
- 2025PI010
- Acronym
- FILFRA
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of a Fracture Liaison Service
- ClinicalTrials.gov ID
- NCT06847776
- Acronym / sponsor ID
- FILFRA / 2025PI010
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, fractures, DXA, CT
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 26 Feb 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients included in the fracture liaison service
Key inclusion criteria (2 listed)
- age >= 50 years
- Bone fracture due to a fall
Key exclusion criteria (1 listed)
- patient's opposition
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
Osteoporosis prevalence on DXA and CT
Time frame: during the evaluation in the fracture liaison service FLS and evry year until 5 years
8 secondary outcomes
prevalnce of treatment for osteoporosis
Time frame: during the evaluation in FLS and every year until 5 years
prevalence of new fractures at 1-3 and 5 years
Time frame: during the evaluation in FLS and at 1, 3 and 5 years
identification of osteoporosis risk factors
Time frame: at the inclusion in FLS
definition of the CT threshold for bone fragility in this population;
Time frame: at the inclusion in FLS
study of the correlation dual x ray absorptiometry and computed tomography bone fragility evaluation
Time frame: at the inclusion in FLS
study of the correlation between FRAX score and DXA
Time frame: at the inclusion in FLS
study of the correlation between FRAX score and Trabecular bone score TBS
Time frame: at the inclusion in FLS
study of the correlation between FRAX score and lean mass
Time frame: at the inclusion in FLS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Central Hospital, Nancy, France 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 1 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: enrolling by invitation, as of the sponsor's last update on 26 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Osteoporosis prevalence on DXA and CT (time frame: during the evaluation in the fracture liaison service FLS and evry year until 5 years). 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 26 Feb 2025.