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

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

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Istituto Ortopedico Rizzoli

Lead sponsor

Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

Collaborator