A microRNA Approach to Discriminate Cortical Low Bone Turnover in Renal Osteodystrophy.
Thomas L Nickolas, Neal Chen, Donald J McMahon...
https://pubmed.ncbi.nlm.nih.gov/32490328/Actively Recruiting
Led by Thomas Nickolas · Updated on 2026-06-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
Renal osteodystrophy ROD is a complex bone disorder caused by kidney failure, affecting nearly all patients with chronic kidney disease CKD. It results in cortical bone loss, fractures, and cardiovascular events. Current treatments aim to reduce high bone turnover caused by kidney-related hormone imbalances, but accurate tools to diagnose low bone turnover are lacking. This research evaluates a new approach using microRNAs as non-invasive biomarkers to better identify bone turnover types in ROD, potentially improving diagnosis and treatment guidance. Participants diagnosed with ROD related to CKD will receive standard bone-targeted treatments prescribed by their doctors. The study involves research activities including blood tests for microRNA analysis, bone scans, and bone biopsies. Data will be collected across four visits over six months to examine the relationship between microRNA levels and bone turnover, as well as bone quality and strength. Throughout the study, participants will complete questionnaires, blood draws, and undergo bone imaging and biopsy procedures. Researchers will compare microRNA profiles with bone biopsy results and bone strength measures to assess the biomarkers accuracy. The study aims to provide a reliable, non-invasive method to guide ROD management. Total participation lasts about six months with multiple evaluations to monitor bone turnover changes and biomarker performance.
CONDITIONS
Precision Medicine Approaches to Renal Osteodystrophy
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Thomas Nickolas
Lead Sponsor
Indiana University
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants complete questionnaires and undergo blood draws, bone scans, and bone biopsy procedures to collect data on bone turnover and quality.
4 visits over six months
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Thomas L Nickolas, Neal Chen, Donald J McMahon...
https://pubmed.ncbi.nlm.nih.gov/32490328/Thomas Nickolas
Lead Sponsor
Indiana University
Collaborating Sponsor