Bone Density in Voluntary Apheresis Blood Donors

Bone Density Clinical Trial

— ALTRUYST  

Official title:

Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655055
• Other study ID #: PRO00026241
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2022
• Source: Versiti
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood donors. The primary outcome measure will be clinically significant decline in BMD at the lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).

Description:

Apheresis blood donation maximizes an individual's donation by selecting specific blood components that are used to save patient lives. Dramatic increases in the number of apheresis procedures performed each year are apparent both domestically and internationally. Apheresis requires the use of citrate anticoagulation, a substance that confers its anticoagulant effect through chelation of cations, like calcium. A small number of cross-sectional studies have reported that intermittent exposure to citrate through apheresis is associated with significant declines in donor bone mineral density (BMD). In contrast, oral potassium citrate of much lower dose has been used to treat low bone density with well-documented efficacy. The impact of citrate exposure during apheresis, either positive or negative, is important given that BMD is a significant risk factor for low trauma fracture, a problem that affects more than 2M people in the U.S. annually. It is ultimately unknown what effect repeated apheresis has on skeletal health. To address this knowledge gap, we will perform a Phase IV clinical trial of apheresis blood donors using a cross-disciplinary, multi-institutional team. As apheresis blood donation continues to affect more people, the importance of understanding the effects of repeated exposure to citrate on donor skeletal health is essential in protecting this precious community resource.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• male
• eligible volunteer blood donor
• = 18, and, = 65 years of age at enrollment
• = 1, and, = 5 prior apheresis blood donation procedures

Exclusion Criteria:

• female
• age < 18 or > 65 years at enrollment
• ineligible for whole blood donation
• BMD Z-score <(-2.0) or >(2.0) at any measurement site upon baseline assessment
• metal prosthesis at measurement site
• weight > 300 lbs (136 kg)
• previous fracture of the lumbar spine or femoral neck
• any fragility fracture, defined as a fracture resulting from a fall of standing height or less, during adulthood (specifically =18 years of age at the time of fracture)
• previous lumbar spinal fusion surgery
• cystic fibrosis
• emphysema
• celiac disease
• Crohn's disease
• Current or past (>1 month duration) use of medications known to affect BMD including, not limited to: (phenytoin, phenobarbital, corticosteroids)
• Current Osteoporosis Medication use including, but not limited to: (Forteo, oral biphosphonates, Reclast, Prolia, calcitonin)
• Unable or unwilling to donate high frequency apheresis

Related Conditions & MeSH terms

• Bone Density

Intervention

Procedure:
• high frequency voluntary apheresis blood donation

Locations

Country	Name	City	State
United States	BloodCenter of Wisconsin	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Versiti	Marquette University, Medical College of Wisconsin, University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual Energy XRay Absorptiometry - Total Lumbar Spine	The primary outcome measure is a decline in total lumbar spine bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA.	one year
Secondary	Dual Energy XRay Absorptiometry - Femoral Neck	A secondary outcome measure includes a decline in left or right femoral neck bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA.	one year
Secondary	Dual Energy XRay Absorptiometry - Total Hip	A secondary outcome measure includes a decline in total hip bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA.	one year
Secondary	Dual Energy XRay Absorptiometry - Total Body Composition		one year