A Study to Analyze Fractures and Bone Disease in Living Kidney Donors

Overview

About this study

The purpose of this study is to to determine whether or not prior living kidney donors have an increased risk of bone fractures. The study will also determine bone structure and health in prior living donors as compared to matched controls.  

 

 

 

 

We will determine if living kidney donors are at increased risk of bone disease and fractures following kidney donation. This information will be valuable in informing future kidney donors of the risks of donation and in devising treatments, such as administration of vitamin D analogs like calcitriol, to prevent such complications.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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. 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Kumar, M.D.

Open for enrollment

Contact information:

Adam Miller B.S.

(507) 266-8147

Miller.Adam@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available