Bone Density in Voluntary Apheresis Blood Donors

NCT02655055 | Completed

• 1 other identifier: PRO00026241
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Bone Density

Keywords

apheresis; citrate anticoagulation; blood donor; bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dual Energy XRay Absorptiometry - Femoral Neck

  one year

• Dual Energy XRay Absorptiometry - Total Hip

  one year

• Dual Energy XRay Absorptiometry - Total Body Composition

  one year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Procedure: high frequency voluntary apheresis blood donation

Control

NO INTERVENTION

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

Interventions

high frequency voluntary apheresis blood donation PROCEDURE

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Versiti Blood Health: lead
• Marquette University: collaborator
• Medical College of Wisconsin: collaborator
• University of Wisconsin, Milwaukee: collaborator

Study Sites (1)

BloodCenter of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Study Officials

• Paula E Papanek, PhD

  Marquette University

  STUDY CHAIR

• Walter Bialkowski, MS

  Versiti Blood Health

  STUDY DIRECTOR

• Robert D Blank, MD, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Jerome L Gottschall, MD

  Versiti Blood Health

  PRINCIPAL INVESTIGATOR

• Cheng Zheng, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 13, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2018
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)