Osteoporosis and Haemophilia

NCT04524481 | Unknown

• 2 other identifiers: NISOSTEO202005292020-003072-41
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis; Haemophilia; Bone Mass

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• haemophilia related clinical data

  10 minutes

• level of physical activity

  non determinable

• orthopaedic joint status

  45 minutes

• pain condition

  15 minutes

• subjective quality of life and subjective physical performance

  10 minutes

Other Outcomes (2)

• blood samples

  non determinable

• Medical history

  10 minutes

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients suffering from other bleeding diseases
• PWH without written consent
• PWH \< 18 years of age
• Secondary osteoporosis

Sponsors & Collaborators

• PD Dr. Andreas Strauß: lead
• Bayer: collaborator

Study Sites (1)

University Hospital of Bonn

Bonn, Northrhine Westfalia, 53127, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40138293 DERIVED

MeSH Terms

Conditions

Osteoporosis; Hemophilia A

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andreas Strauß, PD Dr.

  Medicine of the University of Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Strauß, PD Dr.

CONTACT

004922828714176; andreas.strauss@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist for orthopaedics and trauma surgery

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: August 19, 2020
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)