Bone DensityALTRUYSTNCT02655055
Bone Density in Voluntary Apheresis Blood Donors
A study testing high frequency voluntary apheresis blood donation in people with Bone Density, run by Versiti Blood Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density
- What is being tested?
- high frequency voluntary apheresis blood donation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- eligible volunteer blood donor
- ≥ 18, and, ≤ 65 years of age at enrollment
- ≥ 1, and, ≤ 5 prior apheresis blood donation procedures
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
BloodCenter of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density
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).
Read the 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.
- Conditions
- Bone Density
- Being tested
- high frequency voluntary apheresis blood donation
- Keywords
- apheresis, citrate anticoagulation, blood donor, bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency voluntary apheresis blood donationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | high frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period) Receives: Procedure: high frequency voluntary apheresis blood donation |
| Control | No intervention | no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
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.
Measured: 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.
Measured: one year
Dual Energy XRay Absorptiometry - Total Body Composition
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versiti Blood Health
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, Medical College of Wisconsin, University of Wisconsin, Milwaukee
- Responsible party
- Sponsor
- Investigators
- Paula E Papanek, PhD, Study chair, Marquette UniversityWalter Bialkowski, MS, Study director, Versiti Blood HealthRobert D Blank, MD, PhD, Principal investigator, Medical College of WisconsinJerome L Gottschall, MD, Principal investigator, Versiti Blood HealthCheng Zheng, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655055
- Sponsor's protocol ID
- PRO00026241
- Acronym
- ALTRUYST
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2016
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Longitudinal Study of Apheresis Voluntary Blood Donors' Bone Density
- ClinicalTrials.gov ID
- NCT02655055
- Acronym / sponsor ID
- ALTRUYST / PRO00026241
- Conditions
- Bone Density
- Keywords
- apheresis, citrate anticoagulation, blood donor, bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Versiti Blood HealthUniversity, hospital or other
- Collaborators
- Marquette University, Medical College of Wisconsin, University of Wisconsin, Milwaukee
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: high frequency voluntary apheresis blood donationhigh frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period) |
| Control | No intervention | –no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- eligible volunteer blood donor
- ≥ 18, and, ≤ 65 years of age at enrollment
- ≥ 1, and, ≤ 5 prior apheresis blood donation procedures
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency voluntary apheresis blood donation | Procedure or surgery | Intervention |
Primary outcome
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.
3 secondary outcomes
Dual Energy XRay Absorptiometry - Femoral Neck
Time frame: one year
Dual Energy XRay Absorptiometry - Total Hip
Time frame: one year
Dual Energy XRay Absorptiometry - Total Body Composition
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula E Papanek, PhD study chair
Marquette University
Walter Bialkowski, MS study director
Versiti Blood Health
Robert D Blank, MD, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency voluntary apheresis blood donation in people with Bone Density, run by Versiti Blood Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Energy XRay Absorptiometry - Total Lumbar Spine (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.