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/32490328Actively Recruiting
Age: 18Years +
All Genders
ID05880914
Precision Medicine Approaches to Renal Osteodystrophy
Led by Thomas Nickolas · Updated on 2025-06-27
40
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
T
Thomas Nickolas
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating renal osteodystrophy (ROD), a bone disorder affecting nearly all chronic kidney disease (CKD) patients, which leads to poor bone quality, fractures, and cardiovascular issues. Current treatments aim to reduce high bone turnover caused by kidney-related hormone changes, but existing tools like parathyroid hormone (PTH) and bone-specific alkaline phosphatase (BSAP) are not accurate enough for safe treatment decisions. This study explores a novel microRNA (miRNA) approach as a non-invasive biomarker to better identify bone turnover types and improve ROD management. Participants diagnosed with bone disorders related to CKD will receive standard clinically indicated treatments for bone disease. The study involves multiple research procedures including blood draws for miRNA sequencing, bone scans, and bone biopsies. Data collection occurs over four visits within six months, focusing on correlating miRNA levels with bone turnover and quality. This approach aims to provide a more precise method to guide treatment decisions for ROD. During the study, patients will undergo evaluations including blood tests, bone imaging, biopsies, and questionnaires. Researchers will monitor changes in miRNA related to bone turnover and assess how these changes reflect bone quality and strength. The primary outcomes measure how well the miRNA panel discriminates changes in bone turnover and their relationship to bone quality over five years. Safety and adherence are monitored, and participants contribute data to better understand ROD management over time.
CONDITIONS
Brief Title
Precision Medicine Approaches to Renal Osteodystrophy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Age 18 years or older
- Chronic kidney disease stages 3 to 5D, regardless of kidney transplant status
- Maintenance hemodialysis for at least 3 months if CKD stage 5D
- Receiving clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy, or osteoporosis
- PTH, BSAP, and CTX levels meet defined thresholds for low or high turnover renal osteodystrophy or have bone biopsy evidence of turnover type
You will not qualify if you...
- Receiving or recently stopped treatment in an investigational drug or device study within 30 days
- Receiving investigational procedures or drugs from another study during participation
- Used etelcalcetide, bisphosphonate, denosumab, teriparatide, abaloparatide, or romosozumab within 6 months prior to enrollment unless switching to change bone turnover
- New use of cinacalcet in prior 6 months
- Use of Zoledronic Acid less than 24 months from enrollment for patients with low kidney function
- Anticipated or recent kidney transplant within 1 year
- Solid organ transplant less than 1 year ago
- Unstable medical condition as judged by investigator
- Metabolic bone diseases unrelated to kidney
- Untreated endocrinopathies like hyperthyroidism
- Cancer within last 5 years except certain skin and cervical cancers
- Pregnant or nursing
- Weight over 300 pounds due to scanner limits
- Allergy to tetracycline or demeclocycline
- On non-aspirin anticoagulants that cannot be paused for biopsy
- Unable to complete study visits or comply with procedures
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 6 months
Participants diagnosed with a bone disorder related to chronic kidney disease (CKD) and undergoing clinically indicated treatment for bone disease will be observed and have research assessments collected.
4 visits over six months
Trial Site Locations
Total: 1 location
1
Washington University in St. Louis (WashU)
St Louis, Missouri, United States, 63110
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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