Actively Recruiting
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Led by Istituto Ortopedico Rizzoli · Updated on 2025-08-14
120
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
A
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy patients at risk or attending periodic follow-up or preventive outpatient visits
- Osteopenic patients with an available DXA scan
- Osteoporotic patients (with or without fractures) with an available DXA or DXA prescribed clinically for fractures
- Adults aged 40 years or older of both sexes
- Body Mass Index (BMI) between 18.5 and 29.9
You will not qualify if you...
- Hematopoietic system disorders such as hemolytic, aplastic, or neoplastic anemias
- Coagulation disorders, hereditary or secondary
- Infections including HIV, HBV, or HCV positivity
- Primary or secondary tumors
- Pregnancy or breastfeeding
- Alcohol consumption exceeding 20 grams per day currently or in the past
- Smoking more than 10 cigarettes per day currently or in the past
- Diabetes
- Treatment with drugs that affect blood cell production such as corticosteroids, immunosuppressants, or cytotoxic agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
2
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Italy, 95123
Actively Recruiting
Research Team
A
Alberto Corrado Di Martino
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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