Clinical Validation of BBCT-hip

ConditionOsteoporosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age65-85
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

caucasic post-menopausal women resident in Emilia-Romagna

menopause (>= 45 years)

Disqualifiers

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

Trial population

Resident in Emilia Romagna, Italy

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • CT scan at the femur

    Diagnostic test

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Fractured subjects1 intervention
Group B: Control subjetcs1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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