Using blood cells to improve osteoporosis diagnosis and monitoring
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
This study is testing if checking the health of certain blood cells can help doctors better diagnose and monitor osteoporosis in both men and women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06551155 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the diagnosis and monitoring of osteoporosis by evaluating the vitality of peripheral blood mononuclear cells (PBMCs) in relation to bone metabolism alterations. It focuses on understanding how PBMCs behave in different stages of osteoporosis, particularly considering gender differences. The study will correlate the in vitro viability of PBMCs with Dual-X-ray Absorptiometry (DXA) results to better stratify patients at risk of fractures. By developing a new diagnostic tool based on PBMCs, the study seeks to address the inadequacies of current osteoporosis assessments.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 40 and older, as well as osteopenic and osteoporotic patients with available DXA results.
Not a fit: Patients with hematopoietic disorders, neoplastic diseases, or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and personalized osteoporosis diagnoses, reducing the risk of fractures in patients.
How similar studies have performed: While the approach of using PBMCs for osteoporosis diagnosis is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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) * Diabetes * Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)
Where this trial is running
Bologna and 1 other locations
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco — Catania, Italy (Recruiting)
Study contacts
- Study coordinator: Alberto Corrado Di Martino
- Email: albertocorrado.dimartino@ior.it
- Phone: 0516366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.