Fracture Prediction by Opportunistic Screening for Osteoporosis (OPPORTOS)
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|ClinicalTrials.gov Identifier: NCT03570177|
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : February 5, 2019
|Condition or disease|
|Fractures Related to Skeleton Fragility|
Primary objective: Assessment of the performance of an automatic measurement of vertebral bone mineral density (BMD) on routine abdominal scans for the prediction of fractures (necessitating hospitalization) over 3 years.
- Assessment of the performance of an automatic measurement of lumbar vertebral bone density on routine abdominal scans (performed for other medical indications) for the prediction of fractures (necessitating hospitalization) over 3 years according to the location of fracture (spine, hip, non- spine-non-hip).
- Assessment of the performance of an automatic measurement of lumbar vertebral bone density on routine abdominal scans (performed for other medical indications) for the prediction of fractures (necessitating hospitalization) over 3 years according to age (>= 75 vs < 75) and sex.
- Assessment of the impact of a preventive treatment of patients at high risk of fracture in terms of number of avoided fractures (simulation study)
The study is based on the patients of the Paris University Hospitals / Assistance Publique - Hôpitaux de Paris (AP-HP), the largest hospital entity in Europe, who had, whatever the medical indication, an abdominal CT; the images are stored in the PACS workstation (available since 20076). After legal authorizations, data from the PACS will be merged with data from the national Programme de Médicalisation des Systèmes d'Information (PMSI) database, which records all discharge summaries of public and private hospitals in France. Each summary contains the age and sex of the patient, the motive of admission, described through the diagnosis codes from the International Statistical Classification of Diseases, 10th Revision (ICD-10) and secondary diagnosis, allowing to identify fractures and, among them, neoplastic (on bone metastasis or primary bone cancer) will not be considered as event of interest).
- All legible abdominal scans performed between 20076 and 20132 at AP-HP in subjects of 60 years and older (i.e. those at a priori higher risk of fragility fractures) during an hospital stay and stored on PACS workstation will be used. If a subject performed several abdominal scans, only the first one will be used.
- Vertebral BMD will be calculated automatically with a validated algorithm (in Hounsfield Unit - HU), with the lower attenuation (lower HU) representing less dense bone (i.e. more fragile), at each vertebra from L1 to L4. The algorithm automatically segments the L1-L4 vertebrae, and extracts their overall density based on a number of features extracted.
- clinical data of APHP patients (included vertebral BMD) will be transferred into the AP-HP Clinical Data Repository (CDR).
- Incident fractures will be identified in the national PMSI database (20076-20156). An event will be defined by the occurrence of an incident fracture (excluding polytraumatic fractures and neoplastic fractures) necessitating hospitalization, within 3 years after the abdominal scan.
- Prediction of the occurrence of fracture by vertebral BMD will be assessed.
The source population will be patients 60 years and older (i.e. those at a priori higher risk of fragility fractures because of age) who had abdominal QCT with images stored centrally in the Picture Archiving and Communication System (PACS) of our institution (Assistance Publique Hôpitaux de Paris, AP-HP). AP-HP is the largest university hospital entity in Europe (Greater Paris University Hospitals, 39 hospitals, 23 of which are for acute care, 20,700 beds including 11700 beds for acute care, more than 7 million patients treated and 1.2 million hospitalizations each year in acute care). The PACS has been implemented in 20076, and stores all the images acquired in the AP-HP institution.
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||OPPORTOS : Fracture Prediction by Opportunistic Screening for Osteoporosis|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
the all population (described in eligibility criteria)
- Incident fractures (non-polytraumatic, non-neoplastic) necessitating an hospitalization within 3 years after BMD measurement on abdominal computed tomography (CT). [ Time Frame: first hospitalization for fracture within 3 years ]This event of interest (fracture necessitating an hospitalization) aims to improve the relevance of the data by selecting patients suffering the most severe fractures, i.e. fractures with the highest consequences in morbidity, and even mortality.
- Incident fractures (non-polytraumatic, non neoplastic) of different locations : hip, vertebral, non hip-non vertebral necessitating an hospitalization within 3 years after BMD measurement on abdominal scan . [ Time Frame: first hospitalization for fracture within 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570177
|Contact: Christian ROUX, Pr||33 1 58 41 25 firstname.lastname@example.org|
|Contact: Karine BRIOT, Dr||33 1 58 41 25 email@example.com|
|La Pitié Salpétrière Hospital||Recruiting|
|Paris, France, 75013|
|Contact: Nessima Yelles 33 1 42 16 75 94 firstname.lastname@example.org|
|Principal Investigator:||Christian ROUX, Pr||Assistance Publique - Hôpitaux de Paris|
|Study Chair:||Sofia ZEMOURI||Assistance Publique - Hôpitaux de Paris|