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Status:

COMPLETED

Fractures and Bone Disease in Living Kidney Donors

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

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

Conditions:

Renal Transplant Donor of Left Kidney

Renal Transplant Donor of Right Kidney

Eligibility:

All Genders

50+ years

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) af...

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 frac...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 25 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 4 2023

Estimated Enrollment :

4415 Patients enrolled

Trial Details

Trial ID

NCT04810884

Start Date

June 25 2020

End Date

August 4 2023

Last Update

October 11 2023

Active Locations (1)

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Mayo Clinic

Rochester, Minnesota, United States, 55905