Haemophilia and Bone Loss - PHILEOS Study

Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements.

Recruitment of haemophilic patients during a routine visit at the haemophilia centre.

Information of the subjects that the study requires a BMD measure for all and a blood sampling for patients only.

After inclusion and exclusion criteria have been checked, the subject can sign the consent.

For all subjects, an appointment will be made for BMD measure. For patients and controls: BMD will be measured by Dual Energy X-ray Absorptiometry (DXA) technology, on femoral and lumbar spine (L2-L4) sites.

For patients, fVIII/fIX activity and antigen, thrombin generation potential and plasmatic markers of bone remodelling will be measured centrally.

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