NCT04810884

Fractures and Bone Disease in Living Kidney Donors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,415 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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.

Conditions

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

Timeline

• Start date: 2020-06-25
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2021-03-23
• Last updated: 2023-10-11

Locations

1 site across 1 country: United States