Actively Recruiting
Haemophilia and Bone Loss - PHILEOS Study
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-04-01
480
Participants Needed
23
Research Sites
247 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Haemophilia and Bone Loss - PHILEOS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men aged 20 to 60 years old
- Haemophilia A and B patients aged 20 to 60 years old
- Haemophilic patients with any disease form (mild, moderate, severe) with or without prophylaxis
- Severe Haemophilia A patients with last factor VIII injection more than 48 to 120 hours prior to blood sampling
- Severe Haemophilia B patients with last factor IX injection more than 5 to 21 days prior to blood sampling
You will not qualify if you...
- History of disease known to influence bone metabolism (hyperthyroidism, hyperparathyroidism, hypercorticism, hypogonadism, long-term corticosteroid use)
- Past or present treatment with any osteoporosis medication other than vitamin D or calcium
- Presence of two total hip prostheses
- Documented HIV infection
- Documented HCV infection at cirrhotic stage
- Haemophilic patients with current or past inhibitor anti-factor VIII or IX (>5 Bethesda Units)
- Treatment with HEMLIBRA (Emicizumab) unless prior thrombin generation result is available
- Diseases influencing bone metabolism not related to haemophilia
- Past or present treatment with anti-osteoporotic medication other than vitamin D or calcium
- Presence of two total hip prostheses
- Documented HIV infection
- Documented HCV infection at cirrhotic stage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
BELGIUM - Brussels
Brussels, Belgium
Actively Recruiting
2
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Completed
3
Chu de Bordeaux
Bordeaux, France, 33076
Actively Recruiting
4
Chu Brest Hopital Morvan
Brest, France, 29200
Actively Recruiting
5
HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)
Bron, France
Actively Recruiting
6
CHU Caen
Caen, France
Actively Recruiting
7
Centre Hospitalier Metropole Savoie
Chambéry, France, 73000
Actively Recruiting
8
Chu Cth Estaing Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
9
Chu de Dijon
Dijon, France, 21000
Actively Recruiting
10
Chu Grenoble Alpes
Grenoble, France, 38700
Actively Recruiting
11
CHU Lille
Lille, France
Actively Recruiting
12
Chu La Timone Marseille
Marseille, France, 13010
Actively Recruiting
13
CHU - Saint Eloi
Montpellier, France, 34295
Actively Recruiting
14
CHU Nancy
Nancy, France
Actively Recruiting
15
CHU de Nantes
Nantes, France
Actively Recruiting
16
Chu Necker Paris
Paris, France, 75015
Actively Recruiting
17
APHP - Bicêtre
Paris, France
Actively Recruiting
18
Chu Rennes Hopital Pontchaillou
Rennes, France, 35000
Actively Recruiting
19
CHU de ROUEN
Rouen, France
Actively Recruiting
20
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
21
Chu Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Actively Recruiting
22
MHEK
Budapest, Hungary, 1134
Completed
23
ROMANIA - Bucharest
Bucharest, Romania
Actively Recruiting
Research Team
B
Brigitte TARDY, MD
CONTACT
C
Carine LABRUYERE, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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