ClinicalTrials.gg
RecruitingNCT06270758ValidaBBCT-hipUpdated May 22, 2026

Clinical Validation of BBCT-hip

An observational study in Osteoporosis, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 2 sites in Italy. Open to female participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
65 Years to 85 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Osteoporosis

Keywords

  • hip fracture
  • fracture prediction
  • finite element
  • in silico
  • osteoporotic fracture
03

In context

Osteoporosis

1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 455 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Resident in Emilia Romagna, Italy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • caucasic women resident in Emilia-Romagna
  • menopause (>= 45 years)

Exclusion criteria

Exclusion Criteria:

  • 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 and proton pump inhibitors or aromatase inhibitors
  • Previous femur fractures
  • Presence of hip/knee prosthesis

only for the fracturegroup:

  • presence of fixation devices after the fracture
  • femur fracture due to high energy trauma
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fractured subjects

    Post-menopausal women who have been hospitalised because of a femur fracture.

    Diagnostic Test: CT scan at the femur

  • Control subjetcs

    Post-menopausal women without history of fracture

    Diagnostic Test: CT scan at the femur

Interventions

  • Diagnostic testCT scan at the femur

    Additional CT scan which is not part of the standard clinical path

06

What researchers measure

Primary outcomes

  1. Femoral fracture event

    Time frame: 5 years

  2. BBCT-hip risk prediction

    Time frame: 5 years

Secondary outcomes

  1. T-score

    gold standard parameter for osteoporosis diagnosis

    Time frame: 5 years

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06270758
Responsible party
Sponsor
First posted
Feb 21, 2024
Start date
Nov 7, 2023
Primary completion
Nov 6, 2030 (estimated)
Completion
Nov 6, 2030 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion