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Bone loss in hemophilia: new study measures the hidden risk

NCT ID NCT04384341

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at bone density in 448 men with hemophilia and healthy volunteers to see how common bone loss is. Participants had a bone density scan and some gave blood samples. The goal was to understand if hemophilia itself, not just lack of activity, leads to weaker bones.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

448 people

The number who actually took part.

Started

Jun 2020

Finished

Dec 2024

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.

Ages

20 to 60 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Volunteers : * Healthy men aged between 20 to 60 years old * Haemophilic Patients: * Haemophilia A and B patients, irrespective of the disease form (mild, moderate, severe with or without prophylaxis) * Haemophilic patients aged between 20 to 60 years old * Severe Haemophilia A patients with prophylaxis : last factor VIII injection more than 48 to 120 hours (depending on on the prophylactic treatment) prior blood sampling dedicated to the this research * Severe Haemophilia B patients : last factor IX injection more than 5 to 21 days (depending on the prophylactic treatment) prior blood sampling dedicated to the this research Exclusion Criteria: * Healthy Volunteers: * History of disease known to influence bone metabolism (hyperthyroidism, hyperparathyroidism, hypercorticism, hypogonadism, diseases that require long-term use of corticoids, …) * Past or present treatment with any osteoporotic medication other than Vit D or Ca++ * Presence of two total hip prostheses * HIV documented infection * HCV documented infection (in progress or cured) at cirrhotic stage * Haemophilic Patients: * Haemophilic patients with current or history of inhibitor anti-fVIII or anti-fIX (\>5 Bethesda Units) * Treatment with HEMLIBRA (Emicizumab). Unless it is possible to use a result of thrombin generation prior to this treatment and achieved with a residual rate not greater than or equal to 5%. * History of disease known to influence bone metabolism and not related to haemophilia (hyperthyroidism, hyperparathyroidism, hypercorticism, hypogonadism, diseases that require long-term use of corticoids, …) * Past or present treatment with any anti-osteoporotic medication other than Vit D or Ca++ * Presence of two total hip prostheses * HIV documented infection * HCV documented infection (in progress or cured) at cirrhotic stage

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Conditions

The condition(s) this trial relates to.

hemophilia hemophilia A hemophilia B osteoporosis

As listed by the trial registrant

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

Hemophilia

Contacts and locations

Locations

  • APHP - Bicêtre

    Paris, France

  • BELGIUM - Brussels

    Brussels, Belgium

  • CHU - Saint Eloi

    Montpellier, 34295, France

  • CHU Caen

    Caen, France

  • CHU Lille

    Lille, France

  • CHU Nancy

    Nancy, France

  • CHU de Nantes

    Nantes, France

  • CHU de ROUEN

    Rouen, France

  • CHU de Saint-Etienne

    Saint-Etienne, 42055, France

  • Centre Hospitalier Metropole Savoie

    Chambéry, 73000, France

  • Chu Brest Hopital Morvan

    Brest, 29200, France

  • Chu Cth Estaing Clermont Ferrand

    Clermont-Ferrand, France

  • Chu Grenoble Alpes

    Grenoble, 38700, France

  • Chu La Timone Marseille

    Marseille, 13010, France

  • Chu Necker Paris

    Paris, 75015, France

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Chu Strasbourg - Hôpital de Hautepierre

    Strasbourg, France

  • Chu de Bordeaux

    Bordeaux, 33076, France

  • Chu de Dijon

    Dijon, 21000, France

  • HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)

    Bron, France

  • MHEK

    Budapest, 1134, Hungary

  • ROMANIA - Bucharest

    Bucharest, Romania

  • University Hospital Centre Zagreb

    Zagreb, 10000, Croatia

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