Osteoporosis and Haemophilia

• Conditions: Osteoporosis; Bone Mass; Haemophilia

• Registration Number: NCT04524481
• Lead Sponsor: PD Dr. Andreas Strauß

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.

Study Timeline

• Study Start: 2020-08-19
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-29
• Primary Completion: 2023-02-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).

Trial Locations

Locations (1)

University Hospital of Bonn; 🇩🇪 Bonn, Northrhine Westfalia, Germany