Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
480 participants
INTERVENTIONAL
2020-06-02
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Haemophilic patients
Blood sampling Bone Densitometry (BMD)
Bone densitometry (BMD)
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.
Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements.
Blood sampling for patients only
For patients, fVIII/fIX activity and antigen, thrombin generation potential and plasmatic markers of bone remodelling will be measured centrally.
Healthy volunteers
Bone Densitometry (BMD)
Bone densitometry (BMD)
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.
Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements.
Interventions
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Bone densitometry (BMD)
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.
Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements.
Blood sampling for patients only
For patients, fVIII/fIX activity and antigen, thrombin generation potential and plasmatic markers of bone remodelling will be measured centrally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
60 Years
MALE
Yes
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Brigitte TARDY, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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BELGIUM - Brussels
Brussels, , Belgium
University Hospital Centre Zagreb
Zagreb, , Croatia
Chu de Bordeaux
Bordeaux, , France
Chu Brest Hopital Morvan
Brest, , France
HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)
Bron, , France
CHU Caen
Caen, , France
Centre Hospitalier Metropole Savoie
Chambéry, , France
Chu Cth Estaing Clermont Ferrand
Clermont-Ferrand, , France
Chu de Dijon
Dijon, , France
Chu Grenoble Alpes
Grenoble, , France
CHU Lille
Lille, , France
Chu La Timone Marseille
Marseille, , France
CHU - Saint Eloi
Montpellier, , France
CHU Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
Chu Necker Paris
Paris, , France
APHP - Bicêtre
Paris, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
CHU de ROUEN
Rouen, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Chu Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
MHEK
Budapest, , Hungary
ROMANIA - Bucharest
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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Christine BIRON ANDREANI, MD
Role: primary
BRIGITTE TARDY
Role: primary
References
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Tardy-Poncet B, Play B, Montmartin A, Damien P, Ollier E, Presles E, Garcin A, Tardy B. PHILEOS (haemoPHILia and ostEoporOSis) Study: protocol of a multicentre prospective case-control study. BMJ Open. 2021 Jan 13;11(1):e042283. doi: 10.1136/bmjopen-2020-042283.
Other Identifiers
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2019-A03358-49
Identifier Type: OTHER
Identifier Source: secondary_id
19PH224
Identifier Type: -
Identifier Source: org_study_id
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