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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Fractures related to skeleton fragility (i.e. osteoporotic fractures) represent a growing health problem, as the life expectancy and thus the number of frail elderly subjects is increasing. These fractures are associated with individual and societal consequences. The fractures are responsible for increased disability, chronic pain, and loss of independency. The annual cost of either prevalent or incident osteoporotic-related fractures exceeds the same ratio calculation for many other serious chronic diseases. Mortality risk is increased following osteoporotic fractures. Several classes of osteoporosis therapies are proven to reduce fracture risk, based on placebo controlled trials of 3-5 years duration, including in elderly patients. These data are the rationale for screening of patients at risk of fracture, recognizing that the optimal approach is to identify subjects at risk for major fractures . Bone fragility is related to the decrease of both the quality and the quantity of bone. Bone mineral density (BMD) is a surrogate of bone fragility, with the advantage of being non-invasively measurable, at relevant sites, such as vertebrae and upper extremity of the femur. A low BMD, age, and prevalent fractures are the 3 main determinants of the risk of sustaining a fracture. A low BMD has also been reported as a determinant of all cause mortality risk in the general population. So far, screening of low BMD by QCT has not been recommended because of low availability of the devices, irradiation, and cost. However, a huge number of QCT are performed daily for various medical indications. These thoracic and abdominal QCT carry potential information about vertebral BMD. These data are already available, with no additional cost, patient time, nor radiation exposure. They can be retrospectively (in our study) or prospectively (in the future context of care) analyzed, and are the basis of an opportunistic screening for osteoporosis: this denotes the use of diagnostic QCT scans made for other medical indication to screen for patients at high fracture risk. There is no study of this QCT based measurement as an opportunistic screening for patients at short-term risk for fracture. Opportunistic screening of osteoporosis, by diagnosis of low BMD on abdominal QCT performed for various medical indications, is able to detect subjects at short-term (i.e. over 3 years) risk of fracture (necessitating an hospitalization).

Condition or disease
Fractures Related to Skeleton Fragility

Detailed Description:

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.

Secondary objective:

  • 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.


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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
all subject
the all population (described in eligibility criteria)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women 60 years and older aving an abdominal computed tomography performed between 2007 and 2013 and stored in the PACS which is the database of all images of patients performed at AP-HP, whatever the medical indication.
Criteria

Inclusion Criteria:

  • Men and women 60 years and older (i.e. those at a priori higher risk of fragility fractures):
  • Having an abdominal computed tomography (CT) (Axial or Sagittal slices / Slice thickness of 4mm or better / Presence of the L1 to L4 vertebrae), performed between 2007 and 2013 and stored in the PACS (Picture Archiving and Communication System) which is the database of all images of patients performed at AP-HP, whatever the medical indication

Exclusion Criteria:

  • Abdominal scan not legible (including patients with spine implants, screws and other spinal devices).
  • Impossibility to match the CT scan data with the French Hospital National Database (Programme de Médicalisation des Systèmes d'Information : PMSI)*, which includes all hospitalizations occurring in public and private acute care settings in France, between 2007 and 2016. Probabilistic matching will give incident fracture data during follow-up.
  • Abdominal scan (i.e. any scan including L1 to L4 vertebrae) performed as outpatient care (i.e. not related to an hospital stay)
  • Foreign residents

Information from the National Library of Medicine

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


Contacts
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Contact: Christian ROUX, Pr 33 1 58 41 25 84 christian.roux@aphp.fr
Contact: Karine BRIOT, Dr 33 1 58 41 25 84 karine.briot@aphp.fr

Locations
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France
La Pitié Salpétrière Hospital Recruiting
Paris, France, 75013
Contact: Nessima Yelles    33 1 42 16 75 94    nessima.yelles@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christian ROUX, Pr Assistance Publique - Hôpitaux de Paris
Study Chair: Sofia ZEMOURI Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03570177     History of Changes
Other Study ID Numbers: AOM16095
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
osteoporotic fractures
QCT
BND
automatic measurement

Additional relevant MeSH terms:
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Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases