Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorIstituto Ortopedico Rizzoli
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias)
Coagulation disorders (hereditary or secondary to other disorders)
Infections (including HIV-HBV-HCV positivity)
Neoplastic diseases (primary and/or secondary tumors)
Trial population
Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening), osteopenic patients, and those with osteoporosis (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, with a Body Mass Index (BMI) between 18.5 and 29.9.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
Diagnostic testDiagnostic test based on the vitality and biological activity of peripheral blood mononuclear cells (PBMCs) tested analyzing approximately 2-5 mL of blood from healthy patients and from osteopenic and osteoporotic (both fractured and non-fractured) patients of both genders
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Healthy patients1 intervention
Group B: Osteopenic patients1 intervention
Group C: Non-fractured osteoporotic patients1 intervention
Group D: Fractured osteoporotic patients1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity
The primary outcome is to determine the sensitivity and specificity of the in vitro behavior (vitality, number, size, and differentiation) of PBMCs (peripheral blood mononuclear cells) in relation to different levels of bone metabolism alteration (ranging from osteopenia to fragility fractures).
Time frame
January 2026Secondary outcomes
1
Correlation
The secondary outcomes include the evaluation and correlation of BMD via DXA T-score, vitality, number, size, and differentiation of PBMCs, T lymphocyte subpopulations, pro- and anti-inflammatory factors, platelet-related parameters, and the expression of biochemical markers of bone turnover in blood and serum samples from healthy individuals, as well as from osteopenic and osteoporotic patients (both fractured and non-fractured).
Time frame
January 2026Sponsors and contacts
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Istituto Ortopedico Rizzoli
Lead sponsor
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Collaborator
Source ClinicalTrials.gov