Status:
RECRUITING
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Lead Sponsor:
Istituto Ortopedico Rizzoli
Collaborating Sponsors:
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Conditions:
Osteoporosis
Osteopenia
Eligibility:
All Genders
40+ years
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...
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 scr...
Eligibility Criteria
Inclusion
- 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
- 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)
- Diabetes
- Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)
Key Trial Info
Start Date :
August 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 5 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06551155
Start Date
August 5 2024
End Date
August 5 2026
Last Update
August 14 2025
Active Locations (2)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
2
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, Italy, 95123