Prospective Biomarkers of Bone Metabolism in Hemophilia A

Completed · Phase 3

Conditions studied: Hemophilia, Bone Disease

In brief

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.

Key facts

Study ID

NCT02306694

Run by

Oregon Health and Science University

People needed

16

Starts

2014-12-01

Expected to finish

2018-04-16

Last updated by the study team

2020-04-01

Who can join

Age: 16 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.
• Age > 16 years old
• Currently using ADVATE as FVIII replacement therapy

You may not qualify if…

• Subject or guardian is unwilling or unable to give written informed consent and/or assent
• Joint or muscle bleeding within 2 weeks of Study Day 1
• Presence of a current factor inhibitor (>0.6 BU/mL via Nijmegan-modified Bethesda assay)
• Known collagen vascular bone disease.

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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