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
Qualifiers
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 design
Treatments tested in this trial
- Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
Treatment groups
Sponsors and collaborators
Istituto Ortopedico Rizzoli
Lead sponsor
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Collaborator