Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

Clinical Trial Description

For the treatment of osteoporosis in the general population, a number of drugs reduce BMD (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women. Because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking.

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Renal Osteodystrophy

Clinical Trial Details

NCT number	NCT01675089
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	July 2012
Completion date	May 2014

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