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NCT04384341Completed

Haemophilia and Bone Loss - PHILEOS Study

Haemophilia and Bone Loss PHILEOS Study

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot formation, causing excessive bleeding (mainly haemarthrosis). Osteoporosis is a systemic bone disease characterized by a low bone mineral density (BMD). A decrease of mean BMD has been described in haemophilic patients compared to healthy controls in several studies. So, osteoporosis could be an underestimated haemophilia-related comorbidity. None of the following risk factors (reduced physical activity, joint damage, vitamin D deficiency and /or hepatitis C virus (HCV) infection) has been retained as a cause of osteoporosis in haemophilic patients. Another hypothesis is that bone loss could be directly linked to fVIII or fIX and/or thrombin deficiency. The aim of this study is to evaluate the prevalence of the bone loss in HA and B patients, according to the type, the severity and the presence (or not) of a prophylactic treatment (depending on the age at which it was began) and to compare it to a control population. The investigators will also evaluate the relation between BMD and FVIII, fIX and thrombin potential.

Status (registry)
Completed
Study type
Interventional
Enrollment
448 (actual)
First submitted
5 May 2020
Start date
2 Jun 2020
Primary completion date
12 Dec 2024
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
NCT number
NCT04384341

What you commit to

  • Study type: Interventional
  • Participants enrolled: 448
  • From 2 Jun 2020 to the primary completion date, 12 Dec 2024
  • 23 sites in 5 countries
  • 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.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 20 years to 60 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
BELGIUM - Brussels
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BrusselsBelgiumUnknown status
CHU de Bordeaux
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BordeauxFranceUnknown status
Chu Brest Hopital Morvan
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BrestFranceUnknown status
HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)
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BronFranceUnknown status
CHU Caen
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CaenFranceUnknown status
Centre Hospitalier Métropole Savoie
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ChambéryFranceUnknown status
Chu Cth Estaing Clermont Ferrand
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Clermont-FerrandFranceUnknown status
CHU de DIJON
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DijonFranceUnknown status
CHU Grenoble Alpes
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GrenobleFranceUnknown status
CHU Lille
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LilleFranceUnknown status
Chu - La Timone - Marseille
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MarseilleFranceUnknown status
CHU Saint-Eloi
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MontpellierFranceUnknown status
CHU Nancy
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NancyFranceUnknown status
CHU de Nantes
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NantesFranceUnknown status
Chu Necker Paris
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ParisFranceUnknown status
APHP - Bicêtre
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ParisFranceUnknown status
CHU Rennes - Hopital Pontchaillou
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RennesFranceUnknown status
CHU de Rouen
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RouenFranceUnknown status
Chu de Saint Etienne
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Saint-EtienneFranceUnknown status
CHU Strasbourg - Hôpital de Hautepierre
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StrasbourgFranceUnknown status
University Hospital Centre Zagreb
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ZagrebCroatiaUnknown status
MHEK
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BudapestHungaryUnknown status
ROMANIA - Bucharest
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BucharestRomaniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.