Fractures Related to Skeleton FragilityOPPORTOSNCT03570177
Fracture Prediction by Opportunistic Screening for Osteoporosis
An observational study of Fractures Related to Skeleton Fragility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fractures Related to Skeleton Fragility
- How many people
- 173,720 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women 60 years and older aving an abdominal computed tomography performed between 2007 and 2014 and stored in the PACS which is the database of all images of patients performed at AP-HP, whatever the medical indication.
Who may be able to join
- Men and women 60 years and older (i.e. those at a priori higher risk of fragility fractures because of age). We do not suggest an upper limit for age, as anti-osteoporotic treatments are effective in elderly individuals on the basis of a high risk of fracture.
- having an abdominal scan* in the PACS workstation, whatever the medical indication (Axial or Sagittal slices / Slice thickness of 4mm or better / Presence of the L1 to L4 vertebrae) made during a hospitalization in an APHP hospital between 2007 and 2014.
- We will use the term abdominal scan for any scan involving L1 to L4 vertebrae, i.e. abdominal scans, thoraco-abdominal scans, lombar scans…
Who cannot join
- Abdominal scan not legible by the software used to measure BMD (this includes patients with spine implants, screws and other spinal devices, scans with a part of L1 to L4 vertabrae missing for any reasons, or any other technical reason of non legibility)
- Impossibility to match the CT scan data with the SNDS (including 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 2017. Matching will be performed using probabilistic matching, as described below. It will give incident fracture data during follow-up.
- Foreign resident
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPPORTOS : Fracture Prediction by Opportunistic Screening for Osteoporosis
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).
Read the 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)
- Assessment of classical risk factors of fracture (using SNDS database) and added value of the automatic bone density measurement on fracture risk estimation.
- Prevalence estimation of vertebral fractures (as assessed automatically by the Zebra algorithm) in the population at index date
- Assessment of the impact of IV contrast on the values of the measurements provided by the Zebra algorithm.
- To establish mean values for zebra parameters according to age and gender in subjects without fracture.
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 CT related data (metadata and data issued from the analysis of abdominal CT with the Zebra software) and images are stored in the PACS workstation (available since 2007), and are available through the AP-HP Clinical Data Repository (CDR). After legal authorizations, data from the CDR will be merged with data from the national Programme de Médicalisation des Systèmes d'Information (PMSI) database within the national system of health data SNDS (Système National des Données de Santé), which records all discharge summaries of public and private hospitals in France (i.e. the national PMSI (Programme de Médicalisation des Systèmes d'Information) database) and reimbursed outpatient care (i.e. the DCIR database).
Each summary of the PMSI 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 2007 and 2014 at AP-HP in subjects of 60 years and older (i.e. those at a priori higher risk of fragility fractures) during a 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. The analysis of abdominal CT with the Zebra software will also identify vertebral fractures.
- Clinical data of APHP patients are available in the CDR.
- Incident fractures will be identified in the national PMSI database within the SNDS (2007-2017). 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 incident fracture (as defined above) 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 2007, and stores all the images acquired in the AP-HP institution and related data. These data are available in the CDR.
After legal authorizations, data from the CDR will be merged with data from the SNDS (Système National des Données de Santé) which includes data from the national Programme de Médicalisation des Systèmes d'Information (PMSI).
- Conditions
- Fractures Related to Skeleton Fragility
- Keywords
- osteoporotic fractures, QCT, BND, automatic measurement
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all subject | the all population (described in eligibility criteria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident fractures (non-polytraumatic, non-neoplastic) necessitating an hospitalization within 3 years after BMD measurement on abdominal computed tomography (CT).
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.
Measured: first hospitalization for fracture within 3 years
Secondary outcomes (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 .
Osteoporosis according to the Zebra score
Zebra score with and without contrast agent
Vertebral fracture according to Zebra software
Measured: first hospitalization for fracture within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Oct 2018
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures Related to Skeleton FragilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian ROUX, Pr, Principal investigator, Assistance Publique - Hôpitaux de ParisSofia ZEMOURI, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570177
- Sponsor's protocol ID
- AOM16095
- Acronym
- OPPORTOS
- Status last verified
- May 2024
- First submitted
- 7 Feb 2018
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPPORTOS : Fracture Prediction by Opportunistic Screening for Osteoporosis
- ClinicalTrials.gov ID
- NCT03570177
- Acronym / sponsor ID
- OPPORTOS / AOM16095
- Conditions
- Fractures Related to Skeleton Fragility
- Keywords
- osteoporotic fractures, QCT, BND, automatic measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 173,720 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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)
- Assessment of classical risk factors of fracture (using SNDS database) and added value of the automatic bone density measurement on fracture risk estimation.
- Prevalence estimation of vertebral fractures (as assessed automatically by the Zebra algorithm) in the population at index date
- Assessment of the impact of IV contrast on the values of the measurements provided by the Zebra algorithm.
- To establish mean values for zebra parameters according to age and gender in subjects without fracture.
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 CT related data (metadata and data issued from the analysis of abdominal CT with the Zebra software) and images are stored in the PACS workstation (available since 2007), and are available through the AP-HP Clinical Data Repository (CDR). After legal authorizations, data from the CDR will be merged with data from the national Programme de Médicalisation des Systèmes d'Information (PMSI) database within the national system of health data SNDS (Système National des Données de Santé), which records all discharge summaries of public and private hospitals in France (i.e. the national PMSI (Programme de Médicalisation des Systèmes d'Information) database) and reimbursed outpatient care (i.e. the DCIR database).
Each summary of the PMSI 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 2007 and 2014 at AP-HP in subjects of 60 years and older (i.e. those at a priori higher risk of fragility fractures) during a 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. The analysis of abdominal CT with the Zebra software will also identify vertebral fractures.
- Clinical data of APHP patients are available in the CDR.
- Incident fractures will be identified in the national PMSI database within the SNDS (2007-2017). 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 incident fracture (as defined above) 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 2007, and stores all the images acquired in the AP-HP institution and related data. These data are available in the CDR.
After legal authorizations, data from the CDR will be merged with data from the SNDS (Système National des Données de Santé) which includes data from the national Programme de Médicalisation des Systèmes d'Information (PMSI).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all subject | – | –the all population (described in eligibility criteria) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women 60 years and older aving an abdominal computed tomography performed between 2007 and 2014 and stored in the PACS which is the database of all images of patients performed at AP-HP, whatever the medical indication.
Key inclusion criteria (3 listed)
- Men and women 60 years and older (i.e. those at a priori higher risk of fragility fractures because of age). We do not suggest an upper limit for age, as anti-osteoporotic treatments are effective in elderly individuals on the basis of a high risk of fracture.
- having an abdominal scan* in the PACS workstation, whatever the medical indication (Axial or Sagittal slices / Slice thickness of 4mm or better / Presence of the L1 to L4 vertebrae) made during a hospitalization in an APHP hospital between 2007 and 2014.
- We will use the term abdominal scan for any scan involving L1 to L4 vertebrae, i.e. abdominal scans, thoraco-abdominal scans, lombar scans…
Key exclusion criteria (3 listed)
- Abdominal scan not legible by the software used to measure BMD (this includes patients with spine implants, screws and other spinal devices, scans with a part of L1 to L4 vertabrae missing for any reasons, or any other technical reason of non legibility)
- Impossibility to match the CT scan data with the SNDS (including 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 2017. Matching will be performed using probabilistic matching, as described below. It will give incident fracture data during follow-up.
- Foreign resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian ROUX, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
Sofia ZEMOURI study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures Related to Skeleton Fragility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.