Clinical Validation of BBCT-hip

NCT ID: NCT06270758

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2030-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fractured subjects

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

CT scan at the femur

Intervention Type DIAGNOSTIC_TEST

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

Control subjetcs

Post-menopausal women without history of fracture

CT scan at the femur

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CT scan at the femur

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* caucasic post-menopausal women resident in Emilia-Romagna
* menopause (\>= 45 years)

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 corticosteroids 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rizzoli Orthopaedic Institute

Bologna, , Italy

Site Status RECRUITING

Rizzoli Orthopaedic Institute

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Alessandra Aldieri, PhD

Role: primary

+390516366565

Fabio Baruffaldi

Role: backup

+390516366850

Alessandra Aldieri, PhD

Role: primary

+39 051 636 6565

Fabio Baruffaldi

Role: backup

+ 39 051 6366850

Related Links

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Other Identifiers

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453/2023/Sper/IOR

Identifier Type: -

Identifier Source: org_study_id

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