Prospective Biomarkers of Bone Metabolism in Hemophilia A

• Status: Completed
• Trial end date: 2018-04-16
• Target enrollment: 0
• Participant gender: Male

Summary

One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture outcome data demonstrating the clinical significance of decreased BMD and altered bone biomarkers in the hemophilia population. This study demonstrates that PwH have an increased risk of fracture compared to the general population and that the issue of bone health will increase in importance as the PwH population ages.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Baxter Healthcare Corporation
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.

2. Age > 16 years old

3. Currently using ADVATE as FVIII replacement therapy

Exclusion Criteria:

1. Subject or guardian is unwilling or unable to give written informed consent and/or assent

2. Joint or muscle bleeding within 2 weeks of Study Day 1

3. Presence of a current factor inhibitor (>0.6 BU/mL via Nijmegan-modified Bethesda assay)

4. Known collagen vascular bone disease.