Bone Density in Voluntary Apheresis Blood Donors (ALTRUYST)

Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density

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).

Study Overview

• Status: Completed
• Conditions: Bone Density
• Intervention / Treatment: Procedure: high frequency voluntary apheresis blood donation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • BloodCenter of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; high frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period)	Procedure: high frequency voluntary apheresis blood donation
NO_INTERVENTION: Control; no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Dual Energy XRay Absorptiometry - Total Body Composition		one year

Collaborators and Investigators

• Sponsor: Versiti
• Collaborators: Medical College of Wisconsin; University of Wisconsin, Milwaukee; Marquette University
• Investigators: Study Chair: Paula E Papanek, PhD, Marquette University; Study Director: Walter Bialkowski, MS, Versiti; Principal Investigator: Robert D Blank, MD, PhD, Medical College of Wisconsin; Principal Investigator: Jerome L Gottschall, MD, Versiti; Principal Investigator: Cheng Zheng, PhD, University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (ESTIMATE): January 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: bone; apheresis; citrate anticoagulation; blood donor
• Other Study ID Numbers: PRO00026241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO