A risk model for osteoporotic fractures reusing CT images acquired for other medical reasons
| ISRCTN | ISRCTN72750412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72750412 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Geneva University Hospitals and Faculty of Medicine, University of Bern |
| Funder | Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung |
- Submission date
- 04/11/2025
- Registration date
- 17/11/2025
- Last edited
- 05/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Osteoporosis (OP) is a silent metabolic bone disease resulting in reduced bone mass and leading to increased rates of bone fragility fractures. OP becomes a major challenge for the quality of life and health care costs of our ageing populations. Areal bone mineral density (aBMD) measured by dual energy x-ray absorptiometry (DXA) is the current standard for diagnosis of OP, but this surrogate of bone strength shows limited sensitivity in predicting fragility fractures. In addition, OP is widely under-diagnosed, and the current fracture risk calculators do not or only partially account for a personalised risk of falls and severity of impact. Accordingly, new strategies and new tools to identify patients at high risk of fractures must urgently be explored. The aim of this project was to develop an integrative fragility fracture prediction model and to validate it with a computer tomography (CT) recycling paradigm that exploits CT examinations of the senior population performed for other medical purposes.
In order to develop and validate the required methods and models, a clinical study that assesses the required variables for fall and fracture risk was conducted.
Who can participate?
Community-dwelling older adults aged 65 years and older who underwent a CT scan at one of the study centers that includes the hip region can participate.
What does the study involve?
The study involves a baseline examination (DXA, HR-pQCT in subgroup, physical performance assessment, questionnaire about daily life and medical history) as well as a follow-up period of 3 years during which incident falls and fractures are recorded via phone calls.
What are the possible benefits and risks of participating?
Individuals who participate in the study benefit from a standard osteoporosis assessment that includes a DXA scan and its evaluation by a medical doctor. No particular risks are expected.
Where is the study run from?
The study was run at two medical centers as well as one academic institution:
1) Service of Bone Diseases, Department of Internal Medicine Specialties, Geneva University Hospital, Switzerland
2) Department of Osteoporosis, Inselspital Bern, University Hospital Bern, Switzerland
3) ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland
When is the study starting and how long is it expected to run for?
The first participants were enrolled in February 2021, and the last follow-up calls will be completed by the end of June 2026.
Who is funding the study?
This study is funded by the Swiss National Science Foundation (SNF), grant number 1383584.
Who is the main contact?
christina.wapp@unibe.ch
Contact information
Public, Scientific
Freiburgstrasse 3
Bern
3010
Switzerland
 ORCID ID |
0009-0006-2476-2941 |
|---|---|
| christina.wapp@unibe.ch |
Principal investigator
Freiburgstrasse 3
Bern
3010
Switzerland
| ORCID ID |
0000-0002-4712-7047 |
|---|---|
| Phone | +41 31 684 14 87 |
| philippe.zysset@unibe.ch |
Principal investigator
Avenue de la Roseraie 64
Bâtiment de Recherches Médicales
Genève
1205
Switzerland
| ORCID ID |
0000-0002-1372-4417 |
|---|---|
| Phone | +41 22 379 46 72 |
| serge.ferrari@unige.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicenter observational cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | 48384_Studieninformation_HFV_Kap_2_d_V4.pdf |
| Scientific title | A fragility fracture integrative risk model using CT recycling |
| Study acronym | AFFIRM-CT |
| Study objectives | The overall aim of the AFFIRM-CT project was to develop a mechanistic risk model for hip fracture prediction. In this study, bone densitometry as well as risk factors for falls and fragility fractures were assessed. |
| Ethics approval(s) |
Approved 22/07/2020, Commission cantonale d'éthique de la recherche (CCER) Geneve (Rue Adrien-Lachenal 8, Genève, 1207, Switzerland; +41 22 54 65 101; ccer@etat.ge.ch), ref: 2019-01327 |
| Health condition(s) or problem(s) studied | Fragility fractures and falls in community-dwelling older adults |
| Intervention | Community-dwelling older adults aged 65 years and older who underwent an abdominal CT scan that included the hip were eligible to participate in the study. Enrolled participants were invited for a single visit to the respective medical centre. During the visit, participants underwent DXA scans of the lumbar spine and hip. At the same time, various variables in the field of medical history, cognitive status and physical performance were assessed. A subgroup was undergoing HR-pQCT scans of the distal tibia and radius. After the examination, individuals were followed up for 36 months, and phone calls were made to assess incident falls and fractures. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Incident falls, prospectively recorded via phone calls during 3 years of follow-up |
| Key secondary outcome measure(s) |
Measured using patient records (unless otherwise noted) at baseline: |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 105 Years |
| Sex | All |
| Target sample size at registration | 800 |
| Total final enrolment | 372 |
| Key inclusion criteria | 1. Individuals aged 65 years and older 2. Community-dwelling older adult 3. Having obtained an abdominal CT including the hip (lesser trochanter of the femur visible) |
| Key exclusion criteria | 1. Aged <65 years or having a life expectancy of <1 year 2. Nursing home resident 3. Prior hip fracture or hip prosthesis, unilateral or bilateral 4. Suffering from a bone pathology such as bone metastatic cancer, multiple myeloma, Paget's disease, osteogenesis imperfecta 5. Permanently bedridden or in a wheel-chair 6. Have cognitive impairment with incapacity to provide informed consent |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Bern
3010
Switzerland
Geneva 14
1211
Switzerland
Bern
3010
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The data set is currently in preparation to be published on Zenodo. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in German version 4 |
05/11/2025 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
04/11/2025: Trial's existence confirmed by Commission cantonale d'éthique de la recherche (CCER) Geneve.
