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Blood test may spot bone fracture risk better than X-Rays

NCT ID NCT06551155

Diagnosis Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new blood-based method to diagnose osteoporosis and predict fracture risk. Researchers will analyze the vitality and behavior of certain blood cells from 120 healthy, osteopenic, and osteoporotic adults aged 40 and older. The goal is to see if this approach is more accurate than current bone density scans (DXA) for identifying different stages of bone loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diagnostic test using peripheral blood mononuclear cells (PBMCs)
What this could lead to
If successful, this could provide a more accurate, blood-based way to diagnose osteoporosis and predict fracture risk, potentially reducing misdiagnosis.
What could go wrong
This is an early-stage diagnostic study with 120 participants, so the test may not prove accurate enough for widespread use. It also requires further validation before becoming a standard tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic disease osteoporosis Osteoporotic Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteopenia Osteoporosis Osteoporosis fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

    RECRUITING

    Catania, 95123, Italy

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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