Severe Fragility Fracture Clinical Trial
— CROSSOfficial title:
Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort
| Verified date | October 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 912 |
| Est. completion date | December 2024 |
| Est. primary completion date | September 7, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Cochin | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mortality rate | To study the risk of mortality over 2 years | 2 years | |
| Other | Mortality rate | To study the risk of mortality over 5 years | 5 years | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Primary | 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 | 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 |