Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease — BONAFIDE  

Secondary Hyperparathyroidism Clinical Trial

Official title: Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Clinical Trial Description

Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

• NCT number: NCT00261950
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Completion date: May 2011