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Trial record 48 of 1004 for:    BMD

Bone Density in Voluntary Apheresis Blood Donors (ALTRUYST)

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ClinicalTrials.gov Identifier: NCT02655055
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
Marquette University
Medical College of Wisconsin
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Blood Center of Wisconsin

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).

Condition or disease Intervention/treatment Phase
Bone Density Procedure: high frequency voluntary apheresis blood donation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Dual Energy XRay Absorptiometry - Total Lumbar Spine [ Time Frame: one year ]
    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.


Secondary Outcome Measures :
  1. Dual Energy XRay Absorptiometry - Femoral Neck [ Time Frame: one year ]
    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.

  2. Dual Energy XRay Absorptiometry - Total Hip [ Time Frame: one year ]
    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.

  3. Dual Energy XRay Absorptiometry - Total Body Composition [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655055


Locations
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United States, Wisconsin
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Blood Center of Wisconsin
Marquette University
Medical College of Wisconsin
University of Wisconsin, Milwaukee
Investigators
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Study Chair: Paula E Papanek, PhD Marquette University
Study Director: Walter Bialkowski, MS Blood Center of Wisconsin
Principal Investigator: Robert D Blank, MD, PhD Medical College of Wisconsin
Principal Investigator: Jerome L Gottschall, MD Blood Center of Wisconsin
Principal Investigator: Cheng Zheng, PhD University of Wisconsin, Milwaukee

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Responsible Party: Blood Center of Wisconsin
ClinicalTrials.gov Identifier: NCT02655055     History of Changes
Other Study ID Numbers: PRO00026241
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Blood Center of Wisconsin:
apheresis
citrate anticoagulation
blood donor
bone