Actively Recruiting

Age: 65Years - 85Years
FEMALE
Healthy Volunteers
NCT06270758

Clinical Validation of BBCT-hip

Led by Istituto Ortopedico Rizzoli · Updated on 2025-02-17

300

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Clinical Validation of BBCT-hip

Who Can Participate

Age: 65Years - 85Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caucasian post-menopausal women resident in Emilia-Romagna
  • Menopause at age 45 years or older
  • Female gender
  • Age between 65 and 85 years
Not Eligible

You will not qualify if you...

  • Presence of tumors
  • Not living independently
  • Chronic diseases with severe organ failure
  • Endocrine diseases of parathyroid, thyroid, adrenal gland
  • Intestinal malabsorption
  • Osteomalacia
  • Paget bone disease
  • Rheumatoid arthritis
  • Neurodegenerative diseases
  • Long-term continuous therapy (over 3 months) with corticosteroids, proton pump inhibitors, or aromatase inhibitors
  • Previous femur fractures
  • Presence of hip or knee prosthesis
  • For fracture group: presence of fixation devices after fracture
  • For fracture group: femur fracture caused by high energy trauma

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rizzoli Orthopaedic Institute

Bologna, Italy, 40136

Actively Recruiting

2

Rizzoli Orthopaedic Institute

Bologna, Italy, 40136

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Clinical Validation of BBCT-hip | DecenTrialz