Severe Fragility FractureCROSSNCT02606162
Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort
An observational study of Severe Fragility Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Severe Fragility Fracture
- How many people
- 912 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2016to 8 Jan 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: Men and women hospitalized for severe fragility fractures in response to low-energy trauma
Who may be able to join
- Men and women aged above 60 years, living in France and hospitalized for severe fragility fractures in response to low-energy trauma (e.g., a fall from standing height).
- Vertebral fractures have to be confirmed by an X ray examination.
- To be eligible for the study the patient has to be included and interviewed within 12 weeks of the fracture event's diagnosis. Note : patients in guardianship or curatorship can be included in this protocol.
- Informed and free consent given and form signed and dated
Who cannot join
- Non severe fracture (for example wrist fracture), 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
The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.
Read the detailed description
In France, the burden of osteoporotic fractures has been studied using cross sectional data from the French hospital national database. The availability of fracture liaison service in the main French cities allows the recruitment of a high number of these targeted patients. A large national multicenter, longitudinal, prospective cohort of patients hospitalized for severe osteoporotic fracture, the CROSS cohort ("Cohorte sur les Risques d'une OStéoporose Sévère"), in order to update data on prognosis (refracture, mortality), epidemiology and of severe osteoporotic fractures.
- Conditions
- Severe Fragility Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new severe fracture over 2 years
To assess the incidence of new severe fracture over 2 years in patients hospitalized for a severe fracture
Measured: 2 years
Secondary outcomes (1)
Number of new severe fracture over 5 years
To assess the incidence of new severe fracture over 5 years in patients hospitalized for a severe fracture
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start8 Jun 2016
- Primary completion4 Dec 2020
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Fragility FractureStudies 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
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Karine BRIOT, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606162
- Sponsor's protocol ID
- NI 13018
- Other IDs
- 2014-A01371-46
- Acronym
- CROSS
- Status last verified
- Jan 2026
- First submitted
- 11 Nov 2015
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort
- ClinicalTrials.gov ID
- NCT02606162
- Acronym / sponsor ID
- CROSS / NI 13018
- Conditions
- Severe Fragility Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 17 Nov 2015 (estimated)
- 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 determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.
Detailed description
In France, the burden of osteoporotic fractures has been studied using cross sectional data from the French hospital national database. The availability of fracture liaison service in the main French cities allows the recruitment of a high number of these targeted patients. A large national multicenter, longitudinal, prospective cohort of patients hospitalized for severe osteoporotic fracture, the CROSS cohort ("Cohorte sur les Risques d'une OStéoporose Sévère"), in order to update data on prognosis (refracture, mortality), epidemiology and of severe osteoporotic fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women hospitalized for severe fragility fractures in response to low-energy trauma
Key inclusion criteria (4 listed)
- Men and women aged above 60 years, living in France and hospitalized for severe fragility fractures in response to low-energy trauma (e.g., a fall from standing height).
- Vertebral fractures have to be confirmed by an X ray examination.
- To be eligible for the study the patient has to be included and interviewed within 12 weeks of the fracture event's diagnosis. Note : patients in guardianship or curatorship can be included in this protocol.
- Informed and free consent given and form signed and dated
Key exclusion criteria (2 listed)
- Non severe fracture (for example wrist fracture), 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
Number of new severe fracture over 2 years
Time frame: 2 years
To assess the incidence of new severe fracture over 2 years in patients hospitalized for a severe fracture
1 secondary outcome
Number of new severe fracture over 5 years
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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
Assistance Publique - Hôpitaux de Paris
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 Severe Fragility 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 4 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: finished, as of the sponsor's last update on 29 Jan 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of new severe fracture over 2 years (time frame: 2 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 29 Jan 2026.