NCT06551155Recruiting
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 9 Aug 2024
- Start date
- 5 Aug 2024
- Primary completion date
- 21 Dec 2026
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Diseases
- Osteoporosis
- NCT number
- NCT06551155
What you commit to
- Study type: Observational
- Planned participants: 120
- From 5 Aug 2024 to the primary completion date, 21 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)
Other illness
- 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)
- Diabetes
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.