Study of Parathyroid Hormone Regulation to Improve Bone Density in Adults with Chronic Kidney Disease

What this Trial Is About

Chronic kidney disease CKD affects about 10% of adults and raises the risk of bone fractures, heart disease, and death. This trial studies how controlling parathyroid hormone PTH, which regulates minerals like calcium and phosphate and rises as kidney function declines, might improve bone health. The study aims to see if targeting different PTH levels affects bone mineral density BMD and also explores impacts on artery stiffness, muscle health, bone structure, and quality of life in CKD patients. Participants are randomly assigned to two groups with different PTH targets. One group will receive treatment to lower PTH as soon as it rises above the normal range using medicines like activated vitamin D, phosphate binders, native vitamin D, and calcimetics. The other group will only start treatment if PTH rises above five times the normal limit. Treatments reflect standard care options used in outpatient clinics. During the 18-month study, researchers will measure changes in bone mineral density, artery stiffness, muscle mass and strength, physical function tests, bone histology via biopsy, quality of life, and spinal fractures. PTH levels will be monitored regularly. This study involves outpatient visits for assessments, scans, blood tests, and biopsies to evaluate how different PTH targets affect health outcomes in CKD.

The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bone Mineral Density