OsteoporosisDISCERNNCT06551155
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
An observational study of Osteoporosis and Osteopenia, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial 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 agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis, Osteopenia, Osteoporosis Fracture
- What is being tested?
- Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Aug 2024to 20 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening), osteopenic patients, and those with osteoporosis (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, with a Body Mass Index (BMI) between 18.5 and 29.9.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Francesca Salamanna, PhD, +390516366730, francesca.salamanna@ior.it
- Recruiting
Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
Catania, 95123
Agostino Gaudio, 095317 ext. 844, agostino.gaudio@unict.it
About this study
Official title: 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
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.
Read the 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 screening and diagnosis of osteoporosis (OP) are becoming increasingly essential, particularly considering specific gender differences. In this context, evaluating new methods and innovative techniques is a global challenge. To address this challenge, in 2018, the IRCCS Istituto Ortopedico Rizzoli (IOR) filed a European patent (European Patent No. 3008470, March 21, 2018; Inventors: Fini M, Giardino R, Salamanna F) related to an in vitro method for correlating the vitality of peripheral blood mononuclear cells (PBMCs) with bone metabolism alterations and OP through simple optical microscope observation. Additionally, specific gender-related differences have been observed in the number, size, differentiation time, and gene and protein expression profiles of PBMCs from osteoporotic patients of different sexes. In this context, the purpose of this study is to fully expand and develop the patent filed by IRCCS IOR in 2018 in order to: a) improve the understanding of the mechanisms of action and observed behavior in PBMCs on which the IOR patent is based; b) correlate the in vitro behavior of PBMCs with different levels of bone metabolism alteration (from osteopenia to fragility fractures); c) evaluate the correlation between the Dual-X-ray Absorptiometry (DXA) T-score and other blood factors related to OP (parameters related to platelets, pro- and anti-inflammatory cytokines, lymphocyte subpopulations) with the in vitro behavior of PBMCs in the presence of different levels of bone metabolism alteration, considering specific gender differences.
- Conditions
- Osteoporosis, Osteopenia, Osteoporosis Fracture
- Being tested
- Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
- Keywords
- peripheral blood mononuclear cells, screening, diagnosis
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Osteoporotic Fractures, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Diagnostic test
Diagnostic test based on the vitality and biological activity of peripheral blood mononuclear cells (PBMCs) tested analyzing approximately 2-5 mL of blood from healthy patients and from osteopenic and osteoporotic (both fractured and non-fractured) patients of both genders
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Patients with available DXA results, at risk and in periodic follow-up and/or attending outpatient visits for preventive screening Receives: Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs) | |
| Osteopenic patients | Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions Receives: Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs) | |
| Non-fractured osteoporotic patients | Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions Receives: Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs) | |
| Fractured osteoporotic patients | Patients with available DXA results or prescribed as per clinical practice, enrolled during hospital admissions Receives: Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
The primary outcome is to determine the sensitivity and specificity of the in vitro behavior (vitality, number, size, and differentiation) of PBMCs (peripheral blood mononuclear cells) in relation to different levels of bone metabolism alteration (ranging from osteopenia to fragility fractures).
Measured: January 2026
Secondary outcomes (1)
Correlation
The secondary outcomes include the evaluation and correlation of BMD via DXA T-score, vitality, number, size, and differentiation of PBMCs, T lymphocyte subpopulations, pro- and anti-inflammatory factors, platelet-related parameters, and the expression of biochemical markers of bone turnover in blood and serum samples from healthy individuals, as well as from osteopenic and osteoporotic patients (both fractured and non-fractured).
Measured: January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start5 Aug 2024
- Primary completion21 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551155
- Sponsor's protocol ID
- DISCERN
- Acronym
- DISCERN
- Status last verified
- May 2026
- First submitted
- 9 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salamanna F, Maglio M, Giavaresi G, Pagani S, Giardino R, Fini M. In vitro method for the screening and monitoring of estrogen-deficiency osteoporosis by targeting peripheral circulating monocytes. Age (Dordr). 2015 Aug;37(4):9819. doi: 10.1007/s11357-015-9819-4. Epub 2015 Aug 7.
PubMed 26250906Salamanna F, Maglio M, Borsari V, Giavaresi G, Aldini NN, Fini M. Peripheral Blood Mononuclear Cells Spontaneous Osteoclastogenesis: Mechanisms Driving the Process and Clinical Relevance in Skeletal Disease. J Cell Physiol. 2016 Mar;231(3):521-30. doi: 10.1002/jcp.25134. Epub 2015 Sep 9.
PubMed 26284737Salamanna F, Giardino R, Fini M. Spontaneous osteoclastogenesis: Hypothesis for gender-unrelated osteoporosis screening and diagnosis. Med Hypotheses. 2017 Nov;109:70-72. doi: 10.1016/j.mehy.2017.09.028. Epub 2017 Sep 28.
PubMed 29150298Salamanna F, Maglio M, Sartori M, Tschon M, Fini M. Platelet Features and Derivatives in Osteoporosis: A Rational and Systematic Review on the Best Evidence. Int J Mol Sci. 2020 Mar 4;21(5):1762. doi: 10.3390/ijms21051762.
PubMed 32143494Salamanna F, Brogini S, Di Martino A, Baldini N, Gaudio A, Castellino P, Contartese D, Di Censo C, Giavaresi G, Faldini C, Fini M. Sustainable innovation with a method based on peripheral mononuclear cells to screen, monitor and stratify the population at risk of osteoporosis and fractures - a multicenter cross-sectional trial protocol. Front Endocrinol (Lausanne). 2025 Oct 2;16:1647800. doi: 10.3389/fendo.2025.1647800. eCollection 2025.
PubMed 41113706
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06551155
- Acronym / sponsor ID
- DISCERN / DISCERN
- Conditions
- Osteoporosis, Osteopenia, Osteoporosis Fracture
- Keywords
- peripheral blood mononuclear cells, screening, diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 screening and diagnosis of osteoporosis (OP) are becoming increasingly essential, particularly considering specific gender differences. In this context, evaluating new methods and innovative techniques is a global challenge. To address this challenge, in 2018, the IRCCS Istituto Ortopedico Rizzoli (IOR) filed a European patent (European Patent No. 3008470, March 21, 2018; Inventors: Fini M, Giardino R, Salamanna F) related to an in vitro method for correlating the vitality of peripheral blood mononuclear cells (PBMCs) with bone metabolism alterations and OP through simple optical microscope observation. Additionally, specific gender-related differences have been observed in the number, size, differentiation time, and gene and protein expression profiles of PBMCs from osteoporotic patients of different sexes. In this context, the purpose of this study is to fully expand and develop the patent filed by IRCCS IOR in 2018 in order to: a) improve the understanding of the mechanisms of action and observed behavior in PBMCs on which the IOR patent is based; b) correlate the in vitro behavior of PBMCs with different levels of bone metabolism alteration (from osteopenia to fragility fractures); c) evaluate the correlation between the Dual-X-ray Absorptiometry (DXA) T-score and other blood factors related to OP (parameters related to platelets, pro- and anti-inflammatory cytokines, lymphocyte subpopulations) with the in vitro behavior of PBMCs in the presence of different levels of bone metabolism alteration, considering specific gender differences.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | – | Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Patients with available DXA results, at risk and in periodic follow-up and/or attending outpatient visits for preventive screening |
| Osteopenic patients | – | Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions |
| Non-fractured osteoporotic patients | – | Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Patients with available DXA results, enrolled during outpatient visits and/or emergency room and/or hospital admissions |
| Fractured osteoporotic patients | – | Diagnostic Test: Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Patients with available DXA results or prescribed as per clinical practice, enrolled during hospital admissions |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients (at risk and undergoing periodic follow-up and/or attending outpatient visits for preventive screening), osteopenic patients, and those with osteoporosis (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, with a Body Mass Index (BMI) between 18.5 and 29.9.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)Diagnostic test based on the vitality and biological activity of peripheral blood mononuclear cells (PBMCs) tested analyzing approximately 2-5 mL of blood from healthy patients and from osteopenic and osteoporotic (both fractured and non-fractured) patients of both genders | Diagnostic test | Fractured osteoporotic patients, Healthy patients, Non-fractured osteoporotic patients, Osteopenic patients |
Primary outcome
Sensitivity and specificity
Time frame: January 2026
The primary outcome is to determine the sensitivity and specificity of the in vitro behavior (vitality, number, size, and differentiation) of PBMCs (peripheral blood mononuclear cells) in relation to different levels of bone metabolism alteration (ranging from osteopenia to fragility fractures).
1 secondary outcome
Correlation
Time frame: January 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Results publication: PubMed 26250906Salamanna F, Maglio M, Giavaresi G, Pagani S, Giardino R, Fini M. In vitro method for the screening and monitoring of estrogen-deficiency osteoporosis by targeting peripheral circulating monocytes. Age (Dordr). 2015 Aug;37(4):9819. doi: 10.1007/s11357-015-9819-4. Epub 2015 Aug 7.
- Results publication: PubMed 26284737Salamanna F, Maglio M, Borsari V, Giavaresi G, Aldini NN, Fini M. Peripheral Blood Mononuclear Cells Spontaneous Osteoclastogenesis: Mechanisms Driving the Process and Clinical Relevance in Skeletal Disease. J Cell Physiol. 2016 Mar;231(3):521-30. doi: 10.1002/jcp.25134. Epub 2015 Sep 9.
- Results publication: PubMed 29150298Salamanna F, Giardino R, Fini M. Spontaneous osteoclastogenesis: Hypothesis for gender-unrelated osteoporosis screening and diagnosis. Med Hypotheses. 2017 Nov;109:70-72. doi: 10.1016/j.mehy.2017.09.028. Epub 2017 Sep 28.
- Results publication: PubMed 32143494Salamanna F, Maglio M, Sartori M, Tschon M, Fini M. Platelet Features and Derivatives in Osteoporosis: A Rational and Systematic Review on the Best Evidence. Int J Mol Sci. 2020 Mar 4;21(5):1762. doi: 10.3390/ijms21051762.
- Derived from this study: PubMed 41113706Salamanna F, Brogini S, Di Martino A, Baldini N, Gaudio A, Castellino P, Contartese D, Di Censo C, Giavaresi G, Faldini C, Fini M. Sustainable innovation with a method based on peripheral mononuclear cells to screen, monitor and stratify the population at risk of osteoporosis and fractures - a multicenter cross-sectional trial protocol. Front Endocrinol (Lausanne). 2025 Oct 2;16:1647800. doi: 10.3389/fendo.2025.1647800. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteopenia, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Corrado Di Martino (0516366 ext. 679, albertocorrado.dimartino@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: January 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551155, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.