Osteoporosis and Haemophilia

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524481
• Other study ID #: NISOSTEO20200529
• Secondary ID: 2020-003072-41
• Status: Recruiting
• Start date: August 19, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Bonn
• Contact: Andreas Strauß, PD Dr.
• Phone: 004922828714176
• Email: andreas.strauss[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Mass
• Haemophilia
• Hemophilia A
• Osteoporosis

Locations

Country	Name	City	State
Germany	University Hospital of Bonn	Bonn	Northrhine Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
PD Dr. Andreas Strauß	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood samples	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.	non determinable
Other	Medical history	Medical history and pharmacological treatment will be recorded. Based on these parameters the occurrence of secondary osteoporosis will be assessed.	10 minutes
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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