Bone Density in Voluntary Apheresis Blood Donors (ALTRUYST)

Versiti

Status

Completed

Conditions

Bone Density

Treatments

Procedure: high frequency voluntary apheresis blood donation

Study type

Interventional

Funder types

Other

Identifiers

NCT02655055

PRO00026241

Details and patient eligibility

About

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).

Full 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.

Enrollment

58 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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