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

Completed

• Conditions: Severe Fragility Fracture

• Registration Number: NCT02606162
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Study Start: 2016-06-08
• Primary Completion: 2018-06-08
• Study Completion: 2018-06-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of new severe fracture over 2 years	2 years	To assess the incidence of new severe fracture over 2 years in patients hospitalized for a severe fracture

Secondary Outcome Measures

Name	Time	Method
Number of new severe fracture over 5 years	5 years	To assess the incidence of new severe fracture over 5 years in patients hospitalized for a severe fracture

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France