Hip FracturesFLSSantPauNCT05266755
Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service
A study testing Fracture Territorial Liaison Service afert a Hip fracture in people with Hip Fractures, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The International Osteoporosis Foundation (IOF) and the American Society for Bone Research and Mineral Metabolism recommend the creation and implementation of fracture coordination services (FLS) as the most efficient way to address the problem. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fracture Territorial Liaison Service afert a Hip fracture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2022to 1 Apr 2023
- Phase
- Interventional
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All hip fractures older than 65 years
Who cannot join
- Politraumatic fractures
- Metastasic fractures
Trial locations and contacts
1 site in 1 country.
Spain1 site
Jordi Martin Marcuello
Barcelona, Catalonia, 08041
Jordi M Marcuello, 629315207, jmartinma@santpau.cat
jmartinma@santpau.cat
About this study
The International Osteoporosis Foundation (IOF) and the American Society for Bone Research and Mineral Metabolism recommend the creation and implementation of fracture coordination services (FLS) as the most efficient way to address the problem. FLS has emerged as a new clinical approach that uses coordinated, multidisciplinary care to improve post-fracture outcomes and reduce recurrent fractures. It is a multidisciplinary and protocolized care model that must guarantee:
- Identify fragility fractures and people at risk for a fracture
- Fracture risk assessment
- Indication for treatment or referral
- Improvement in therapeutic compliance
- Reduce the risk of falls It is known that patients who have undergone a FLS model (vs no FLS), have lower mortality, lower risk of fracture, with a reduction of 35% and 56%, respectively, during two years of follow-up. One of the most important objectives of the FLS is the proper recognition and treatment of osteoporosis (OP) in patients with fragility fractures. A major problem is the lack of adherence to treatment for OP, and inclusion in an FLS program increases the prescription of bisphosphonates from 17.9% to 76%. In addition, a specific follow-up program means that 73% of patients followed by FLS continue to undergo anti-resorptive treatment after 2 years of having suffered a femur fracture.
Read the detailed description
Hypothesis After a femur fracture due to fragility, upon discharge from surgery at the Hospital de la Santa Creu i Sant Pau, including patients in a regional FLS program will make it possible to complete the study of the patient with fracture, improve adherence to treatment of OP (secondary prevention), and obtain better functional recovery.
- Conditions
- Hip Fractures
- Being tested
- Fracture Territorial Liaison Service afert a Hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture Territorial Liaison Service afert a Hip fractureOther
Give a diferent than the current one way of follow up to the patients with hip fracture
| Study group | Role | What they receive |
|---|---|---|
| Patiens who will receive stanrdar care after hip fracture | Placebo comparator | All the patients who will be on surgery after a hip fracture will receive after the hospital discharge the standar following we are doing now in our hospital Receives: Other: Fracture Territorial Liaison Service afert a Hip fracture |
| Patiens who will receive FLS following after the hip fracture | Active comparator | All the patients who will be on surgery after a hip fracture will receive after the hospital discharge a FLS following, multidisciplinary, with a web and mobile app aplication Receives: Other: Fracture Territorial Liaison Service afert a Hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths
% of Number of deaths after 1st year o follow up
Measured: 1 year after discharge
Number of Falls
Number of Falls 1st year o follow up
Measured: 1 year after discharge
Percentage of patients with adequated Osteoporotic treatment
Percentage of patients with adequated osteoporotic treatment
Measured: 1 year after discharge
Secondary outcomes (1)
Barthel at the end of follow up
Compare Barthel after hospital discharge with the end of follow up barthel. Minimum is 0 maximum is 100.
Measured: 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter clinical trial. Adult patients who consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for an FxF PSM as a primary or secondary diagnosis will be selected and will be randomized with a 1:1 distribution to be included in the FLS -CTSPau (intervention group) or to receive usual care (control group). The result of the intervention will be evaluated in terms of health outcomes (re-consultations, hospital readmissions and quality of life).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266755
- Sponsor's protocol ID
- IIBSP-FLS-2021-114
- Acronym
- FLSSantPau
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martin Marcuello J, Rodolico A, Britez Carli ML, Puig Campmany M, Blazquez Andion M, de Caso Rodriguez J, Gomis Pastor M, Real Gatius J, de Dios Lopez A, Fradejas Moschino S, Pallares E, Alburquerque J, Lluch Targarona MDM, Mascaro Lamarca J. A territorially coordinated, eHealth-supported fracture liaison service following femur fragility fracture: a pilot randomised controlled trial. Osteoporos Int. 2026 Sep 28. doi: 10.1007/s00198-026-08219-8. Online ahead of print.
PubMed 42803811
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service
- ClinicalTrials.gov ID
- NCT05266755
- Acronym / sponsor ID
- FLSSantPau / IIBSP-FLS-2021-114
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 4 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 International Osteoporosis Foundation (IOF) and the American Society for Bone Research and Mineral Metabolism recommend the creation and implementation of fracture coordination services (FLS) as the most efficient way to address the problem. FLS has emerged as a new clinical approach that uses coordinated, multidisciplinary care to improve post-fracture outcomes and reduce recurrent fractures. It is a multidisciplinary and protocolized care model that must guarantee:
- Identify fragility fractures and people at risk for a fracture
- Fracture risk assessment
- Indication for treatment or referral
- Improvement in therapeutic compliance
- Reduce the risk of falls It is known that patients who have undergone a FLS model (vs no FLS), have lower mortality, lower risk of fracture, with a reduction of 35% and 56%, respectively, during two years of follow-up. One of the most important objectives of the FLS is the proper recognition and treatment of osteoporosis (OP) in patients with fragility fractures. A major problem is the lack of adherence to treatment for OP, and inclusion in an FLS program increases the prescription of bisphosphonates from 17.9% to 76%. In addition, a specific follow-up program means that 73% of patients followed by FLS continue to undergo anti-resorptive treatment after 2 years of having suffered a femur fracture.
Detailed description
Hypothesis After a femur fracture due to fragility, upon discharge from surgery at the Hospital de la Santa Creu i Sant Pau, including patients in a regional FLS program will make it possible to complete the study of the patient with fracture, improve adherence to treatment of OP (secondary prevention), and obtain better functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter clinical trial. Adult patients who consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for an FxF PSM as a primary or secondary diagnosis will be selected and will be randomized with a 1:1 distribution to be included in the FLS -CTSPau (intervention group) or to receive usual care (control group). The result of the intervention will be evaluated in terms of health outcomes (re-consultations, hospital readmissions and quality of life).
| Arm | Type | Receives |
|---|---|---|
| Patiens who will receive stanrdar care after hip fracture | Placebo comparator | Other: Fracture Territorial Liaison Service afert a Hip fractureAll the patients who will be on surgery after a hip fracture will receive after the hospital discharge the standar following we are doing now in our hospital |
| Patiens who will receive FLS following after the hip fracture | Active comparator | Other: Fracture Territorial Liaison Service afert a Hip fractureAll the patients who will be on surgery after a hip fracture will receive after the hospital discharge a FLS following, multidisciplinary, with a web and mobile app aplication |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All hip fractures older than 65 years
Key exclusion criteria (2 listed)
- Politraumatic fractures
- Metastasic fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fracture Territorial Liaison Service afert a Hip fractureGive a diferent than the current one way of follow up to the patients with hip fracture | Other | Patiens who will receive FLS following after the hip fracture, Patiens who will receive stanrdar care after hip fracture |
Primary outcome
Number of Deaths
Time frame: 1 year after discharge
% of Number of deaths after 1st year o follow up
Number of Falls
Time frame: 1 year after discharge
Number of Falls 1st year o follow up
Percentage of patients with adequated Osteoporotic treatment
Time frame: 1 year after discharge
Percentage of patients with adequated osteoporotic treatment
1 secondary outcome
Barthel at the end of follow up
Time frame: 1 year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 42803811Martin Marcuello J, Rodolico A, Britez Carli ML, Puig Campmany M, Blazquez Andion M, de Caso Rodriguez J, Gomis Pastor M, Real Gatius J, de Dios Lopez A, Fradejas Moschino S, Pallares E, Alburquerque J, Lluch Targarona MDM, Mascaro Lamarca J. A territorially coordinated, eHealth-supported fracture liaison service following femur fragility fracture: a pilot randomised controlled trial. Osteoporos Int. 2026 Sep 28. doi: 10.1007/s00198-026-08219-8. Online ahead of print.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture Territorial Liaison Service afert a Hip fracture in people with Hip Fractures, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi M Marcuello, Doctor (629315207, jmartinma@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Deaths (time frame: 1 year after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05266755, which also lists 1 linked publication.
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 18 Mar 2022.