Osteoporosis and Haemophilia

Study Overview
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Brief Summary
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The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.

Detailed Description
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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.

Official Title
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Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis

Conditions
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Haemophilia, Bone Mass, Osteoporosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with mild haemophilia A or B<br>(FVIII or IX >5 %, ≥ 18 years' old) | |
| Patients with moderate haemophilia A or B<br>(FVIII or IX 1-5 %, ≥ 18 years' old) | |
| Patients with severe haemophilia A or B<br>(FVIII or IX <1 %, ≥ 18 years' old) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mass/bone density maesurement | 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. | 15 minutes | 
| blood sample (Vit. D/Calcium) | 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. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemophilia related clinical data | 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. | 10 minutes | 
| level of physical activity | 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. | non determinable | 
| orthopaedic joint status | The clinical joint status will be examined in all patients with haemophilia by the World Federation Joint Examination Score and Haemophilia Joint Health Score. | 45 minutes | 
| pain condition | 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. | 15 minutes | 
| subjective quality of life and subjective physical performance | 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). | 10 minutes |