Renal Osteodystrophy Clinical Trial
Official title:
A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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