Bone Density in Voluntary Apheresis Blood Donors

NCT ID: NCT02655055

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-04-30

Brief 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).

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.

Conditions

Bone Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Intervention

high frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period)

Group Type: EXPERIMENTAL

high frequency voluntary apheresis blood donation

Intervention Type: PROCEDURE

Control

no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

high frequency voluntary apheresis blood donation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: collaborator

Versiti

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula E Papanek, PhD

Role: STUDY_CHAIR

Marquette University

Walter Bialkowski, MS

Role: STUDY_DIRECTOR

Versiti

Robert D Blank, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Jerome L Gottschall, MD

Role: PRINCIPAL_INVESTIGATOR

Versiti

Cheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

BloodCenter of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00026241

Identifier Type: -

Identifier Source: org_study_id