Phase 3 Completed N=16 Treatment

Prospective Biomarkers of Bone Metabolism in Hemophilia A

Hemophilia · Bone Disease

Source: ClinicalTrials.gov NCT02306694 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcomePrimary: Bone Biomarker Density (BMD) — -0.74; -0.16; -0.16 Z-Score

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Biomarker Density (BMD)	-0.74; -0.16; -0.16	—
PRIMARY Joint Health	19.91	—
PRIMARY Quality of Life Using the VAS and EQ-5D-3L	6.92; 82.42	—
PRIMARY Plasma Cytokine Concentration Differences From 0-hour to 24-hour	2.04; 0.03; -7.73; -2.84; -6.72; 0.12	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02306694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.