Precision Medicine Approaches to Renal Osteodystrophy (PMaROD)
Renal Osteodystrophy, Chronic Kidney Diseases, CKD-MBD
About this trial
This is an interventional other trial for Renal Osteodystrophy focused on measuring Bone biopsy, microRNA, HR-pQCT, Bone biomarkers, Bone imaging
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Currently receiving treatment in an investigational device or drug study, or less than 30 days since ending treatment on an investigational device or drug study(s) Currently receiving investigational procedures/drugs from another study while participating in this study Use of etelcalcetide, bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab during the 6 months prior to study enrollment; however, participant can be included if being treated with bone active agent but will have class change to an agent that will result in a change in bone turnover from low to high or high to low New use of cinacalcet over the prior 6 months Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR <30mL/minute Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant For patients with a solid organ transplant, less than 1 year from receiving the transplant Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator Metabolic bone diseases not related to the kidney (e.g., Paget's, Osteogenesis Imperfecta) Endocrinopathy (e.g., untreated hyperthyroidism) Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ) Patient is pregnant or nursing Weight >300 pounds (scanner limitation) Allergy to tetracycline or demeclocycline Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy Patient unable to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient and Investigator's knowledge
Sites / Locations
- Columbia University Irving Medical CenterRecruiting
Arms of the Study
Arm 1
Other
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.