OsteoporosisValidaBBCT-hipNCT06270758
Clinical Validation of BBCT-hip
An observational study of Osteoporosis, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial summary
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- CT scan at the femur
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Nov 2023to 6 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Resident in Emilia Romagna, Italy
Who may be able to join
- caucasic post-menopausal women resident in Emilia-Romagna
- menopause (>= 45 years)
Who cannot join
- tumours
- not free living
- Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
- Long-term continuous therapy (>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
- Previous femur fractures
- Presence of hip/knee prosthesis
Show all 9Show fewer
- only for the fracturegroup:
- presence of fixation devices after the fracture
- femur fracture due to high energy trauma
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Rizzoli Orthopaedic Institute
Bologna, 40136
Alessandra Aldieri, PhD, +390516366565, alessandra.aldieri@ior.it
Fabio Baruffaldi, +390516366850, fabio.baruffaldi@ior.it
- Recruiting
Rizzoli Orthopaedic Institute
Bologna, 40136
Alessandra Aldieri, PhD, +39 051 636 6565, alessandra.aldieri@polito.ior.ir
Fabio Baruffaldi, + 39 051 6366850, fabio.baruffaldi@ior.it
About this study
Official title: Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.
- Conditions
- Osteoporosis
- Being tested
- CT scan at the femur
- Keywords
- hip fracture, fracture prediction, finite element, in silico, osteoporotic fracture
- Medical subject headings
- Osteoporosis, Hip Fractures, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan at the femurDiagnostic test
Additional CT scan which is not part of the standard clinical path
| Study group | Role | What they receive |
|---|---|---|
| Fractured subjects | Post-menopausal women who have been hospitalised because of a femur fracture. Receives: Diagnostic Test: CT scan at the femur | |
| Control subjetcs | Post-menopausal women without history of fracture Receives: Diagnostic Test: CT scan at the femur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral fracture event
Measured: 5 years
BBCT-hip risk prediction
Measured: 5 years
Secondary outcomes (1)
T-score
gold standard parameter for osteoporosis diagnosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start7 Nov 2023
- Primary completion6 Nov 2030 (estimated)
- Study completion6 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270758
- Sponsor's protocol ID
- 453/2023/Sper/IOR
- Acronym
- ValidaBBCT-hip
- Status last verified
- May 2026
- First submitted
- 14 Feb 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
- ClinicalTrials.gov ID
- NCT06270758
- Acronym / sponsor ID
- ValidaBBCT-hip / 453/2023/Sper/IOR
- Conditions
- Osteoporosis
- Keywords
- hip fracture, fracture prediction, finite element, in silico, osteoporotic fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 6 Nov 2030 (estimated)
- Study completion
- 6 Nov 2030 (estimated)
- First posted
- 21 Feb 2024 (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.
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractured subjects | – | Diagnostic Test: CT scan at the femurPost-menopausal women who have been hospitalised because of a femur fracture. |
| Control subjetcs | – | Diagnostic Test: CT scan at the femurPost-menopausal women without history of fracture |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Resident in Emilia Romagna, Italy
Key inclusion criteria (2 listed)
- caucasic post-menopausal women resident in Emilia-Romagna
- menopause (>= 45 years)
Key exclusion criteria (9 listed)
- tumours
- not free living
- Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
- Long-term continuous therapy (>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
- Previous femur fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan at the femurAdditional CT scan which is not part of the standard clinical path | Diagnostic test | Control subjetcs, Fractured subjects |
Primary outcome
Femoral fracture event
Time frame: 5 years
BBCT-hip risk prediction
Time frame: 5 years
1 secondary outcome
T-score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Publication about BBCT-hip methodologyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral fracture event (time frame: 5 years). The study lists 2 primary outcomes in all. 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 22 May 2026.