Evaluating bone loss in patients with hemophilia
Haemophilia and Bone Loss PHILEOS Study
This study is trying to see how bone loss affects people with hemophilia and if their blood factor levels relate to osteoporosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | Male |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | Emicizumab |
| Locations | 23 sites (Brussels and 22 other locations) |
| Trial ID | NCT04384341 on ClinicalTrials.gov |
What this trial studies
This study investigates the prevalence of bone loss in patients with Hemophilia A and B, focusing on the relationship between factor deficiencies and osteoporosis. Healthy volunteers and hemophilic patients aged 20 to 60 will undergo bone mineral density (BMD) measurements using Dual Energy X-ray Absorptiometry (DXA). Blood samples will be collected from hemophilic patients to assess factor activity and markers of bone remodeling. The study aims to better understand the comorbidities associated with hemophilia and their impact on bone health.
Who should consider this trial
Good fit: Ideal candidates include men aged 20 to 60 with Hemophilia A or B, regardless of disease severity.
Not a fit: Patients with a history of diseases affecting bone metabolism or those on specific osteoporosis medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for osteoporosis in hemophilic patients.
How similar studies have performed: While the relationship between hemophilia and bone health is being explored, this specific approach to evaluating bone loss in hemophilic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels and 22 other locations
- BELGIUM - Brussels — Brussels, Belgium (Recruiting)
- University Hospital Centre Zagreb — Zagreb, Croatia (Completed)
- Chu de Bordeaux — Bordeaux, France (Recruiting)
- Chu Brest Hopital Morvan — Brest, France (Recruiting)
- HCL - Groupement Hospitalier Est (Hôpital Louis Pradel) — Bron, France (Recruiting)
- CHU Caen — Caen, France (Recruiting)
- Centre Hospitalier Metropole Savoie — Chambéry, France (Recruiting)
- Chu Cth Estaing Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
- Chu de Dijon — Dijon, France (Recruiting)
- Chu Grenoble Alpes — Grenoble, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Chu La Timone Marseille — Marseille, France (Recruiting)
- CHU - Saint Eloi — Montpellier, France (Recruiting)
- CHU Nancy — Nancy, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- Chu Necker Paris — Paris, France (Recruiting)
- APHP - Bicêtre — Paris, France (Recruiting)
- Chu Rennes Hopital Pontchaillou — Rennes, France (Recruiting)
- CHU de ROUEN — Rouen, France (Recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
- Chu Strasbourg - Hôpital de Hautepierre — Strasbourg, France (Recruiting)
- Mhek — Budapest, Hungary (Completed)
- ROMANIA - Bucharest — Bucharest, Romania (Recruiting)
Study contacts
- Principal investigator: Brigitte TARDY, MD — CHU de Saint Etienne
- Study coordinator: Brigitte TARDY, MD
- Email: brigitte.tardy@chu-st-etienne.fr
- Phone: (0)477421877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.