Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation|
- Differences in bone turnover [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.
- Bone microarchitecture [ Time Frame: 1 year ] [ Designated as safety issue: No ]Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months.
- Changes in Bone Mineral Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]Bone mineral density (BMD) measurements by dual-energy X-ray absorptiometry (DEXA) will be made at the time of transplant and after 6 and 12 months.
|Study Start Date:||July 2012|
|Study Completion Date:||May 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Zoledronic acid
Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.
Drug: Zoledronic acid
The treatment group will receive 15-minute intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml.
Other Name: Aclasta
No Intervention: Control
The control group will receive only vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675089
|Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo|
|Sao Paulo, Brazil, 05403-900|
|Principal Investigator:||Elias David-Neto, MD||University of Sao Paulo|