Precision Medicine Approaches to Renal Osteodystrophy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Study participant has provided informed consent

• Age ≥ 18 years

• CKD Stages 3-5D regardless of kidney transplantation status

• CKD5D patients receiving maintenance hemodialysis for at least 3 months

• Clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy and/or Osteoporosis

• PTH, BSAP and CTX meets defined thresholds for low or high turnover ROD type or a Bone biopsy evidence of low or high turnover based

Locations
United States
Missouri
Washington University in St. Louis (WashU)
RECRUITING
St Louis
Time Frame
Start Date: 2022-12-21
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 40
Treatments
Bone-targeted management - prospective cohort
Participants diagnosed with a bone disorder related to chronic kidney disease (CKD) and undergoing a clinically indicated treatment for bone disease. Participants will have some questionnaires, research blood draws, bone scans and a bone biopsy. There will be a total of 4 visits over six months for data collection.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University School of Medicine
Leads: Thomas Nickolas

This content was sourced from clinicaltrials.gov