Clinical trial NCT04810884: Fractures and Bone Disease in Living Kidney Donors
Official title: Fractures and Bone Disease in Living Kidney Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant Donor of Left Kidney
Renal Transplant Donor of Right Kidney
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-23
Enrollment: 4415
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors
timeFrame: Baseline
measure: Changes in bone health after kidney donation
timeFrame: Day 1
measure: Incidence of differences in bone architecture and strength after kidney donation
timeFrame: Day 1
measure: Incidence of changes in blood counts and blood chemistry measures after kidney donation
timeFrame: Day 1
measure: Assess the correlations of bone biomarker and serum hormone concentrations with bone mineral density.
timeFrame: Day 1
measure: Assess the correlations of renal function with bone mineral health.
timeFrame: Day 1
Secondary outcomes:
measure: Explore how vertebral Trabecular Bone Score (TBS) correlates with measures of bone health.
timeFrame: Day 1
measure: Evaluate Advanced Glycation Endproducts (AGEs) correlation to bone health parameters.
timeFrame: Day 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rajiv Kumar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: