Osteoporosis and Haemophilia

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis; Haemophilia; Bone Mass

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Germany
  • Northrhine Westfalia
    • Bonn, Northrhine Westfalia, Germany, 53127
      • Recruiting
      • University Hospital of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with mild haemophilia A or B; (FVIII or IX >5 %, ≥ 18 years' old)
Patients with moderate haemophilia A or B; (FVIII or IX 1-5 %, ≥ 18 years' old)
Patients with severe haemophilia A or B; (FVIII or IX <1 %, ≥ 18 years' old)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Medical history	Medical history and pharmacological treatment will be recorded. Based on these parameters the occurrence of secondary osteoporosis will be assessed.	10 minutes

Collaborators and Investigators

• Sponsor: PD Dr. Andreas Strauß
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Blood Coagulation Disorders; Bone Diseases, Metabolic; Hemophilia A; Osteoporosis
• Other Study ID Numbers: NISOSTEO20200529; 2020-003072-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The publication of anonymous patient data is not allowed by informed consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No