Fractures Related to Skeleton Fragility Clinical Trial
— OPPORTOSOfficial title:
OPPORTOS : Fracture Prediction by Opportunistic Screening for Osteoporosis
| Verified date | May 2024 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Active, not recruiting |
| Enrollment | 173720 |
| Est. completion date | January 2025 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | Inclusion Criteria: - 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… Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | La Pitié Salpétrière Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | first hospitalization for fracture within 3 years | |
| Secondary | 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 |
first hospitalization for fracture within 3 years |