Bone Density in Voluntary Apheresis Blood Donors

Completed · Not applicable

Conditions studied: Bone Density

In brief

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).

Key facts

Study ID

NCT02655055

Run by

Versiti Blood Health

People needed

58

Starts

2016-05-01

Expected to finish

2018-04-01

Last updated by the study team

2022-03-09

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

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)
• Unable or unwilling to donate high frequency apheresis

Where it is running

• BloodCenter of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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