NCT04384341Completed
Haemophilia and Bone Loss - PHILEOS Study
Haemophilia and Bone Loss PHILEOS Study
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 448 (actual)
- First submitted
- 5 May 2020
- Start date
- 2 Jun 2020
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Haemophilia, Osteoporosis
- NCT number
- NCT04384341
What you commit to
- Study type: Interventional
- Participants enrolled: 448
- From 2 Jun 2020 to the primary completion date, 12 Dec 2024
- 23 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 60 years · Sex: Male · Accepts healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BELGIUM - Brussels Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Chu Brest Hopital Morvan Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| HCL - Groupement Hospitalier Est (Hôpital Louis Pradel) Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| Chu Cth Estaing Clermont Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Chu - La Timone - Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU Saint-Eloi Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Chu Necker Paris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| APHP - Bicêtre Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| CHU Strasbourg - Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| MHEK Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| ROMANIA - Bucharest Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.