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Phase 3 N=16 Treatment

Prospective Biomarkers of Bone Metabolism in Hemophilia A

Hemophilia · Bone Disease

Bottom Line

View on ClinicalTrials.gov: NCT02306694 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Bone Biomarker Density (BMD) — -0.74; -0.16; -0.16 Z-Score

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Advate (Drug)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
Male
Sponsor
Oregon Health and Science University
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-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 —

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.

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.

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