Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

NCT ID: NCT02606162

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

912 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-08

Study Completion Date

2018-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Fragility Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karine BRIOT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Cochin

Paris, Paris, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-A01371-46

Identifier Type: OTHER

Identifier Source: secondary_id

NI 13018

Identifier Type: -

Identifier Source: org_study_id