Osteoporosis and Haemophilia

NCT ID: NCT04524481

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-19

Study Completion Date

2023-03-01

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.

Conditions

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Osteoporosis Haemophilia Bone Mass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with mild haemophilia A or B

(FVIII or IX \>5 %, ≥ 18 years' old)

No interventions assigned to this group

Patients with moderate haemophilia A or B

(FVIII or IX 1-5 %, ≥ 18 years' old)

No interventions assigned to this group

Patients with severe haemophilia A or B

(FVIII or IX \<1 %, ≥ 18 years' old)

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

PD Dr. Andreas Strauß

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Andreas Strauß

specialist for orthopaedics and trauma surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andreas Strauß, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Medicine of the University of Bonn

Locations

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University Hospital of Bonn

Bonn, Northrhine Westfalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Strauß, PD Dr.

Role: CONTACT

Phone: 004922828714176

Email: [email protected]

Facility Contacts

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Andreas Strauß, PD Dr.

Role: primary

References

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Ransmann P, Bruhl M, Hmida J, Goldmann G, Oldenburg J, Schildberg FA, Ossendorff R, Tomschi F, Schmidt A, Hilberg T, Strauss AC. Physical activity and handgrip strength in patients with mild, moderate and severe haemophilia: Impacts on bone quality and lean mass. PLoS One. 2025 Mar 26;20(3):e0319951. doi: 10.1371/journal.pone.0319951. eCollection 2025.

Reference Type DERIVED
PMID: 40138293 (View on PubMed)

Other Identifiers

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2020-003072-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NISOSTEO20200529

Identifier Type: -

Identifier Source: org_study_id