Clinical trial NCT02655055: Bone Density in Voluntary Apheresis Blood Donors
Official title: Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Density
Keywords: apheresis
citrate anticoagulation
blood donor
bone
Lead sponsor: Versiti
Sponsor class: OTHER
Collaborators: name: Marquette University
name: Medical College of Wisconsin
name: University of Wisconsin, Milwaukee
First posted: 2016-01-13
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Dual Energy XRay Absorptiometry - Total Lumbar Spine
timeFrame: one year
Secondary outcomes:
measure: Dual Energy XRay Absorptiometry - Femoral Neck
timeFrame: one year
measure: Dual Energy XRay Absorptiometry - Total Hip
timeFrame: one year
measure: Dual Energy XRay Absorptiometry - Total Body Composition
timeFrame: one year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Paula E Papanek, PhD
role: STUDY_CHAIR
affiliation: Versiti
name: Walter Bialkowski, MS
role: STUDY_DIRECTOR
affiliation: Medical College of Wisconsin
name: Robert D Blank, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Versiti
name: Jerome L Gottschall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Milwaukee
name: Cheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: