Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
MALE
Healthy Volunteers
NCT04384341

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

Age: 20Years - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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