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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Fragility Fracture

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 Type: Observational
• Enrollment (Actual): 912

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hôpital COCHIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women hospitalized for severe fragility fractures in response to low-energy trauma

Description

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 6 weeks of the fracture event.
• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	To study the risk of mortality over 2 years	2 years
Mortality rate	To study the risk of mortality over 5 years	5 years
Type of severe fracture	To study the role of refracture on mortality after adjustment for prefracture health status; To study the risk factors and phenotypes of patients hospitalized for severe fracture and to compare them between each type of severe fracture (hip,subtrochanteric, vertebrae, pelvis, humerus)	3 months after inclusion and each year during 5 years
Number of patients who receive antiosteoporotic treatments and/or calcium and/or vitamin D and/or falls prevention	To check the implementation of 2012 French guidelines, including on the basis on number of performed bone densitometry	3 months after inclusion and each year during 5 years
Quality of life assessed by questionnaire Euroqol (EQ5D) and questionnaire (SF-36)	To assess and compare the quality of life between each type of severe fracture	3 months after inclusion and each year during 5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: Karine BRIOT, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2016
• Primary Completion (ANTICIPATED): September 7, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (ESTIMATE): November 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Osteoporotic Fractures
• Other Study ID Numbers: NI 13018; 2014-A01371-46 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO