Bone Density in Voluntary Apheresis Blood Donors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density

Conditions
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Bone Density

Intervention / Treatment
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* Procedure: high frequency voluntary apheresis blood donation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>high frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period) | Procedure: high frequency voluntary apheresis blood donation<br> <br> |
| No Intervention: Control<br>no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Energy XRay Absorptiometry - Femoral Neck | A secondary outcome measure includes a decline in left or right femoral neck bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA. | one year | 
| Dual Energy XRay Absorptiometry - Total Hip | A secondary outcome measure includes a decline in total hip bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA. | one year | 
| Dual Energy XRay Absorptiometry - Total Body Composition |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apheresis, citrate anticoagulation, blood donor, bone