Haemophilia and Bone Loss PHILEOS Study

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Biological, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Belgium
BELGIUM - Brussels
RECRUITING
Brussels
Croatia
University Hospital Centre Zagreb
COMPLETED
Zagreb
France
Chu de Bordeaux
RECRUITING
Bordeaux
Chu Brest Hopital Morvan
RECRUITING
Brest
HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)
RECRUITING
Bron
CHU Caen
RECRUITING
Caen
Centre Hospitalier Metropole Savoie
RECRUITING
Chambéry
Chu Cth Estaing Clermont Ferrand
RECRUITING
Clermont-ferrand
Chu de Dijon
RECRUITING
Dijon
Chu Grenoble Alpes
RECRUITING
Grenoble
CHU Lille
RECRUITING
Lille
Chu La Timone Marseille
RECRUITING
Marseille
CHU - Saint Eloi
RECRUITING
Montpellier
CHU Nancy
RECRUITING
Nancy
CHU de Nantes
RECRUITING
Nantes
APHP - Bicêtre
RECRUITING
Paris
Chu Necker Paris
RECRUITING
Paris
Chu Rennes Hopital Pontchaillou
RECRUITING
Rennes
CHU de ROUEN
RECRUITING
Rouen
CHU de Saint-Etienne
RECRUITING
Saint-etienne
Chu Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
Hungary
MHEK
COMPLETED
Budapest
Romania
ROMANIA - Bucharest
RECRUITING
Bucharest
Contact Information
Primary
Brigitte TARDY, MD
brigitte.tardy@chu-st-etienne.fr
(0)477421877
Backup
Carine LABRUYERE, CRA
carine.labruyere@chu-st-etienne.fr
(0)477120469
Time Frame
Start Date: 2020-06-02
Estimated Completion Date: 2025-03
Participants
Target number of participants: 480
Treatments
Experimental: Haemophilic patients
Blood sampling Bone Densitometry (BMD)
Other: Healthy volunteers
Bone Densitometry (BMD)
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov