Skip to main content
OpenTrials
Completed

NCT Number: NCT04810884

Fractures and Bone Disease in Living Kidney Donors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Transplant Donor of Left Kidney Renal Transplant Donor of Right Kidney

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aim 1: Survey (Donors):

  • Donated a kidney at one of the three participating sites.
  • 10 or more years have passed since donation.
  • Age ≥ 50 at time of study enrollment.

Aim 1: Survey (Controls):

  • Subjects in the REP population.
  • Medical records available for the five years preceding age at matching (age at donation).
  • Matching will be based on: age, year of donation, sex, race/ethnicity, body mass index, comorbidity and selected risk factors (smoking, education level) status at year of donation

Aim 2: Skeletal health assessment (Donors and Controls):

  • Subjects who have completed the survey
  • Willing to come in for the in-person assessment

Exclusion criteria

Aim 1: Survey (Donors):

  • Deceased
  • Not willing to return the survey.

Aim 1: Survey (Controls):

  • Deceased
  • Not willing to return the survey
  • History of the following conditions:
  • Diabetes mellitus, liver disease, kidney disease, nephrolithiasis, malabsorption syndrome, past history of non-traumatic fractures.

Aim 2: Skeletal health assessment (Donors and Controls):

  • Subjects who did not participate in the survey
  • Subjects not willing to come for the in-person evaluation.
  • Women of childbearing potential.

Treatment and study plan

Primary outcomes

  1. Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors

    Time frame: Baseline

    Measured by participant self-report response to survey about bone fractures and bone health survey

  2. Changes in bone health after kidney donation

    Time frame: Day 1

    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.

  3. Incidence of differences in bone architecture and strength after kidney donation

    Time frame: Day 1

    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.

  4. Incidence of changes in blood counts and blood chemistry measures after kidney donation

    Time frame: Day 1

    Based on variations between donors and non-donors in measures of complete blood count, serum electrolytes, Ca, Pi, creatinine, blood urea nitrogen and albumin.

  5. Assess the correlations of bone biomarker and serum hormone concentrations with bone mineral density.

    Time frame: Day 1

    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).

  6. Assess the correlations of renal function with bone mineral health.

    Time frame: Day 1

    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.

Secondary outcomes

  1. Explore how vertebral Trabecular Bone Score (TBS) correlates with measures of bone health.

    Time frame: Day 1

    Trabecular bone score (TBS), a measure of bone quality, will be assessed from existing DXA images.

  2. Evaluate Advanced Glycation Endproducts (AGEs) correlation to bone health parameters.

    Time frame: Day 1

    The AGEs Reader will measure the accumulations of AGEs in tissues in kidney donors and controls.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.