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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Sensitivity and specificity
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Detailed Description
Inadequate assessment, diagnosis, and stratification of patients with bone mass loss can lead to an increased risk of osteoporotic fractures. Therefore, alternative and advanced methods to support screening and diagnosis of osteoporosis (OP) are becoming increasingly essential, particularly considering specific gender differences. In this context, evaluating new methods and innovative techniques is a global challenge. To address this challenge, in 2018, the IRCCS Istituto Ortopedico Rizzoli (IOR) filed a European patent (European Patent No. 3008470, March 21, 2018; Inventors: Fini M, Giardino R, Salamanna F) related to an in vitro method for correlating the vitality of peripheral blood mononuclear cells (PBMCs) with bone metabolism alterations and OP through simple optical microscope observation. Additionally, specific gender-related differences have been observed in the number, size, differentiation time, and gene and protein expression profiles of PBMCs from osteoporotic patients of different sexes. In this context, the purpose of this study is to fully expand and develop the patent filed by IRCCS IOR in 2018 in order to: a) improve the understanding of the mechanisms of action and observed behavior in PBMCs on which the IOR patent is based; b) correlate the in vitro behavior of PBMCs with different levels of bone metabolism alteration (from osteopenia to fragility fractures); c) evaluate the correlation between the Dual-X-ray Absorptiometry (DXA) T-score and other blood factors related to OP (parameters related to platelets, pro- and anti-inflammatory cytokines, lymphocyte subpopulations) with the in vitro behavior of PBMCs in the presence of different levels of bone metabolism alteration, considering specific gender differences.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •Pregnancy or breastfeeding
- •Alcohol consumption (\>20 g of alcohol per day currently or in the past)
- •Smoking (\>10 cigarettes per day, currently or in the past)
- •Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)
Outcomes
Primary Outcomes
Sensitivity and specificity
Time Frame: January 2026
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).
Secondary Outcomes
- Correlation(January 2026)