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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1
Mayo Clinic
Rochester, Minnesota, United States, 55905