NCT02306694

Prospective Biomarkers of Bone Metabolism in Hemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Male
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a pilot study to determine the impact of factor replacement on bone biomarkers in up to 20 hemophilia A subjects. Subjects will be recruited over 1 year for the 5-day protocol. Following a 72-hour washout period, factor levels and bone biomarkers will be followed before and after 50 units/kg replacement on Day 1 and 20 units/kg replacement on Day 3. Each subject can serve as their Figure 4. Fracture rates in PwH compared to historic controls.

Conditions

• Hemophilia
• Bone Disease

Interventions

Type	Name	Description
DRUG	Advate	Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2014-12-03
• Last updated: 2020-04-01
• Results posted: 2020-03-24

Locations

1 site across 1 country: United States