Informations générales (source: ClinicalTrials.gov)

NCT04384341 En recrutement IDF
Haemophilia and Bone Loss PHILEOS Study (PHILEOS)
Interventional
  • Hémophilie A
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
juin 2020
mars 2025
02 avril 2025
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Necker-Enfants Malades LAURENT FRENZEL, MD En recrutement IDF Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Metropole Savoie - 73000 - Chambéry - France ROMAIN JAILLER, MD En recrutement Contact (sur clinicalTrials)
Chu Brest Hopital Morvan - 29200 - Brest - France BRIGITTE PAN-PETESCH, MD En recrutement Contact (sur clinicalTrials)
Chu Cth Estaing Clermont Ferrand - Clermont-Ferrand - France AURELIEN LEBRETON, MD En recrutement Contact (sur clinicalTrials)
Chu Grenoble Alpes - 38700 - Grenoble - France RAPHAEL MARLU, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHP - Bicêtre - Paris - France Roseline D'OIRON, MD En recrutement Contact (sur clinicalTrials)
CHU - Saint Eloi - 34295 - Montpellier - France Christine BIRON ANDREANI, MD En recrutement Contact (sur clinicalTrials)
CHU Caen - Caen - France Yohann REPESSE, MD En recrutement Contact (sur clinicalTrials)
Chu de Bordeaux - 33076 - Bordeaux - France SABINE CASTET, MD En recrutement Contact (sur clinicalTrials)
Chu de Dijon - 21000 - Dijon - France FABIENNE GENRE-VOLLOT, MD En recrutement Contact (sur clinicalTrials)
CHU de Nantes - Nantes - France Marc FOUASSIER, MD En recrutement Contact (sur clinicalTrials)
CHU de ROUEN - Rouen - France PIERRE CHAMOUNI, MD En recrutement Contact (sur clinicalTrials)
CHU de Saint-Etienne - 42055 - Saint-Étienne - France BRIGITTE TARDY En recrutement Contact (sur clinicalTrials)
Chu La Timone Marseille - 13010 - Marseille - France CELINE FALAISE, MD En recrutement Contact (sur clinicalTrials)
CHU Lille - Lille - France Antoine RAUCH, MD En recrutement Contact (sur clinicalTrials)
CHU Nancy - Nancy - France Birgit FROTSCHER En recrutement Contact (sur clinicalTrials)
Chu Rennes Hopital Pontchaillou - 35000 - Rennes - France BENOIT GUILLET, MD En recrutement Contact (sur clinicalTrials)
Chu Strasbourg - Hôpital de Hautepierre - Strasbourg - France DOMINIQUE DESPREZ, MD En recrutement Contact (sur clinicalTrials)
HCL - Groupement Hospitalier Est (Hôpital Louis Pradel) - Bron - France Anne LIENHART, MD En recrutement Contact (sur clinicalTrials)

Critères

Homme
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


- 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