An observational study in Renal Transplant Donor of Left Kidney and Renal Transplant Donor of Right Kidney, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Mayo Clinic · Observational
This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Certain chemicals in the body that help maintain bone health were shown to have changed after kidney donation in living donors, whether or not these changes lead to a decrease in bone quality and increase the risk of fractures is not known.
The purpose of this study is to compare the bone health of living kidney donors, with the bone health of non-kidney donors. This information will be helpful in informing future kidney donors of the risks of donation and in creating treatments to help prevent these complications.
This is an observational study that consists of two Aims:
Aim 1 is a survey sent to 3000 prior living kidney donors and 3000 matched controls. The survey contains questions about history of bone fractures and general bone health. Prior living kidney donors will be identified and surveyed from three Minnesota centers: Mayo Clinic, Rochester; Hennepin County Medical Center (HCMC); and the University of Minnesota (UMN).
Aim 2 of this study includes an assessment of bone structure and bone turnover markers in a subset of donors and matched controls. 200 prior living kidney donors and 200 matched controls will be invited to Mayo Clinic Rochester's CRTU for an assessment of bone health. Each subject will undergo lateral DXA with VFA assessment, bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment(µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.
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Living kidney donors who are more than 10 years post donation and who are 50 years of age or older at the time of study enrollment and matched controls.
Aim 1: Survey (Donors):
Aim 1: Survey (Controls):
Aim 2: Skeletal health assessment (Donors and Controls):
Exclusion Criteria:
Aim 1: Survey (Donors):
Aim 1: Survey (Controls):
History of the following conditions:
Aim 2: Skeletal health assessment (Donors and Controls):
Aim 1: A survey about fractures and general bone health will be sent to 3000 prior living kidney donors. Aim 2: Out of these 3000 subjects, 200 prior living kidney donors who are ≥10 years post kidney donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.
Aim 1: A survey about fractures and general bone health will be sent to 3000 age, sex, race, and comorbidity-matched subjects who would have been eligible to donate but did not donate a kidney. Aim 2: Out of these 3000 subjects, 200 control subjects who would be eligible to donate, but have not donated, and are matched by age, sex, race, and comorbidity to donors at the time of donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.
Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors
Measured by participant self-report response to survey about bone fractures and bone health survey
Time frame: Baseline
Changes in bone health after kidney donation
As indicated by comparisons between kidney donors and non-donors of dual-energy X-ray absorptiometry (DXA) measurements of bone mineral density at the lumbar spine (L1-L4), total hip and distal 1/3 of the forearm (GE Lunar) by DXA. Will be expressed as a T-score offset from expected peak bone mass as contained in the DXA scanner manufacturers' database.
Time frame: Day 1
Incidence of differences in bone architecture and strength after kidney donation
By comparisons of kidney donors and non-donors in measures of volumetric density and bone microarchitecture at the distal radius and tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). Bone strength will be evaluated using Image Processing Language (IPL) software to generate microfinite element (μFE) models from HR-pQCT imaging.
Time frame: Day 1
Incidence of changes in blood counts and blood chemistry measures after kidney donation
Based on variations between donors and non-donors in measures of complete blood count, serum electrolytes, Ca, Pi, creatinine, blood urea nitrogen and albumin.
Time frame: Day 1
Assess the correlations of bone biomarker and serum hormone concentrations with bone mineral density.
Based on comparison of bone and serum biomarkers in kidney donors and non-donors: (NTX; CTX; TRAcP5b; OC; BAP; P1NP; sclerostin assay); 1,25(OH)2D; 25(OH)D2 and 25(OH)D3; parathyroid hormone (PTH); fibroblast growth factor-23 (FGF23).
Time frame: Day 1
Assess the correlations of renal function with bone mineral health.
Renal function will be assessed by Measured Glomerular Filtration Rate (GFR), using the iothalamate short renal clearance technique, and by 24 hour urine collection to record the measures of creatinine clearance, urinary excretion of calcium, phosphorus, albumin and protein.
Time frame: Day 1
Explore how vertebral Trabecular Bone Score (TBS) correlates with measures of bone health.
Trabecular bone score (TBS), a measure of bone quality, will be assessed from existing DXA images.
Time frame: Day 1
Evaluate Advanced Glycation Endproducts (AGEs) correlation to bone health parameters.
The AGEs Reader will measure the accumulations of AGEs in tissues in kidney donors and controls.
Time frame: Day 1
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