Identification, Monitoring, and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening)

• Osteopenic patients with an available DXA

• Osteoporotic patients (fractured and non-fractured) with an available DXA or, for fractured patients, a DXA prescribed as part of clinical practice

• Aged ≥ 40 years of both sexes

• Body Mass Index (BMI) between 18.5 and 29.9

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
RECRUITING
Catania
Contact Information
Primary
Alberto Corrado Di Martino
albertocorrado.dimartino@ior.it
0516366
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2026-08-05
Participants
Target number of participants: 120
Treatments
Healthy patients
Patients with available DXA results, at risk and in periodic follow-up and/or attending outpatient visits for preventive screening
Osteopenic patients
Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions
Non-fractured osteoporotic patients
Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions
Fractured osteoporotic patients
Patients with available DXA results or prescribed as per clinical practice, enrolled during hospital admissions
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli
Collaborators: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

This content was sourced from clinicaltrials.gov