RecruitingNCT05880914

Precision Medicine Approaches to Renal Osteodystrophy


Sponsor

Thomas Nickolas

Enrollment

40 participants

Start Date

Dec 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insufficient accuracy for turnover type to safely and confidently guide treatment of renal osteodystrophy. In the present investigation, the investigators will study a microRNA approach as a novel non-invasive biomarker of turnover for renal osteodystrophy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at personalized treatment approaches for kidney bone disease — a common complication of chronic kidney disease (CKD) where the bones weaken and break down, or sometimes form too slowly. Researchers want to understand how different bone-affecting medications should be chosen and monitored based on individual bone biology. **You may be eligible if...** - You are 18 or older with chronic kidney disease stage 3–5 (including those on dialysis or with a kidney transplant) - You are on maintenance hemodialysis for at least 3 months - You need treatment for kidney-related bone disease, hyperparathyroidism, or osteoporosis - Your bone markers meet specific thresholds for low or high bone turnover **You may NOT be eligible if...** - You received certain bone medications (bisphosphonates, denosumab, teriparatide, etc.) in the past 6 months (unless switching to a different class) - You are scheduled for a kidney transplant within the study period or received one within the past year - You have a bone disease unrelated to kidney disease (e.g., Paget's disease) - You are pregnant or breastfeeding - You weigh over 300 pounds (due to scanner limits) - You are allergic to tetracycline antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREmiRNAseq analysis

Identify miRNA in serum and prepare a miRNA sequencing library for novel analysis.

DRUGStandard treatment for bone disorder

Participants will be prescribed a clinically indicated bone-targeted treatment for osteoporosis or bone disorder related to CKD. (non-experimental)


Locations(1)

Washington University in St. Louis (WashU)

St Louis, Missouri, United States

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NCT05880914


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