Prospective Biomarkers of Bone Metabolism in Hemophilia A

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02306694
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	Phase 3
Start date	December 2014
Completion date	April 16, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05617209` - In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients
Completed	`NCT05039008` - Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy	N/A
Recruiting	`NCT04398628` - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed	`NCT02546622` - ATHN 2: Factor Switching Study
Unknown status	`NCT02165592` - Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia	N/A
Terminated	`NCT02586012` - Weight-based Dosing in Hemophilia A	Phase 2
Unknown status	`NCT02433782` - Myofascial Therapy in Patients With Hemophilic Arthropathy	N/A
Completed	`NCT02165462` - Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy	N/A
Completed	`NCT01232634` - Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles	Phase 2
Completed	`NCT05104164` - Self-myofascial Release in Hemophilic Ankle Arthropathy	N/A
Terminated	`NCT01191372` - First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients	Phase 1
Completed	`NCT05173129` - Posture Analysis for Patients With Haemophilia	N/A
Completed	`NCT03818529` - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Withdrawn	`NCT03996486` - Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia	Phase 1
Completed	`NCT01708564` - A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B	Phase 1
Completed	`NCT03842605` - Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia	N/A
Completed	`NCT05549843` - Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle	N/A
Recruiting	`NCT06010953` - SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment	Phase 1/Phase 2
Completed	`NCT05027230` - A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor	Phase 1/Phase 2
Not yet recruiting	`NCT06014320` - Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease