Bone Mass, Haemophilia, Osteoporosis
Conditions
Brief summary
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.
Detailed description
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Subsequently, the ascertained prevalence of osteoporosis in patients with haemophilia will be compared to the latest published data of osteoporosis in Germany. Furthermore, the impact of severity of haemophilia, comorbidities as well as the role of both physical activity and individual joint condition as influencing factors on the presence of osteoporosis will be analysed by this study.
Interventions
None listed
Sponsors
Bayer
PD Dr. Andreas Strauß
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX \>5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX \<1 %) haemophilia A or B * Submitted written consent to participate in the study
Exclusion criteria
* Patients suffering from other bleeding diseases * PWH without written consent * PWH \< 18 years of age * Secondary osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood sample (Vit. D/Calcium) | 10 minutes | The blood samples of all patients with haemophilia will be tested according to the guidelines of the confederation of osteology (DVO). These blood samples are necessary to assess the osteoporosis by measuring the Vitamin-D and Calcium level. |
| bone mass/bone density maesurement | 15 minutes | All patients with haemophilia of this study will receive a standardised bone density measurement by using the same dual energy X-ray absorptiometry (DXA) device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of physical activity | non determinable | In order to assess the individual level of physical activity, an individual movement profile will be created. For this purpose, the activity of each patient with haemophilia will be recorded by an electronic activity tracker. In addition, the grade of individual physical activity will be assessed on the basis of questionnaires. |
| pain condition | 15 minutes | The pain condition will be examined in terms of pressure pain thresholds. By using an algometer device (Wagner Instruments, USA) with a robe area of 1 cm2 the individual pain sensitivity will be measured. |
| subjective quality of life and subjective physical performance | 10 minutes | The examination of these parameters is carried out by the standardised questionnaires SF-36 (quality of life) and the HEP-Test-Q (subjective physical performance). |
| orthopaedic joint status | 45 minutes | The clinical joint status will be examined in all patients with haemophilia by the World Federation Joint Examination Score and Haemophilia Joint Health Score. |
| haemophilia related clinical data | 10 minutes | All patients with haemophilia record their individual substitution regime and bleeding events in individual patients' diaries. The patients are used to record and submit all necessary information about bleeding events, factor replacement regime. By doing so, the individual treatment regime per week as well as the annual (joint) bleeding rate will be assessed one year retrospectively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical history | 10 minutes | Medical history and pharmacological treatment will be recorded. Based on these parameters the occurrence of secondary osteoporosis will be assessed. |
| blood samples | non determinable | Blood samples of all PWH will be tested according to the guidelines of the confederation of osteology (DVO). Additionally, the liver's (GGT, GPT, GOT) and parathyroid glands' (PTH) function will be assessed and patient's will also be tested for testosterone-deficiency (testosterone), diabetes (HbA1c) and multiple myeloma (paracentesis). Furthermore these blood samples are necessary to define the immune phenotype (including: soluble mediators such as cytokines and growth factors, as well as the cellular immune composition, immune cell subsets and their detailed phenotype) to examine a possible correlation with the severity of osteoporosis. |
Countries
Germany
Contacts
Primary ContactAndreas Strauß, PD Dr.
Outcome results
None listed