Clinical trial NCT02606162: Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort
Official title: Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Fragility Fracture
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2015-11-17
Enrollment: 912
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women hospitalized for severe fragility fractures in response to low-energy trauma

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of new severe fracture over 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Number of new severe fracture over 5 years
timeFrame: 5 years
Other outcomes:
measure: Mortality rate
timeFrame: 2 years
measure: Mortality rate
timeFrame: 5 years
measure: Type of severe fracture
timeFrame: 3 months after inclusion and each year during 5 years
measure: Number of patients who receive antiosteoporotic treatments and/or calcium and/or vitamin D and/or falls prevention
timeFrame: 3 months after inclusion and each year during 5 years
measure: Quality of life assessed by questionnaire Euroqol (EQ5D) and questionnaire (SF-36)
timeFrame: 3 months after inclusion and each year during 5 years
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karine BRIOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: