Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810884
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-02-15
Brief Title:
Fractures and Bone Disease in Living Kidney Donors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Fractures and Bone Disease in Living Kidney Donors
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Rochesters 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 assessmentµFEA skin AGEs measurement and blood collection to measure markers of bone formation and resorption
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 Rochesters 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 assessmentµFEA skin AGEs measurement and blood collection to measure markers of bone formation and resorption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK125252 | NIH | None | httpsreporternihgovquickSearchR01DK125252 |