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Precision Medicine Approaches to Renal Osteodystrophy

NCT05880914 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

  • Renal Osteodystrophy
  • Chronic Kidney Diseases
  • CKD-MBD
  • Bone Turnover Rate Disorder
  • Secondary Hyperparathyroidism

Interventions

PROCEDURE

miRNAseq analysis

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

DRUG

Standard treatment for bone disorder

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

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

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

    collaborator NIH

  • Thomas Nickolas

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2026-08-17
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05880914 on ClinicalTrials.gov