Clinical Trial: Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation

Brief 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.

Detailed Summary:

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.


Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Differences in bone turnover [ Time Frame: 1 year ]

Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bone microarchitecture [ Time Frame: 1 year ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: August 23, 2012
Date Started: July 2012
Date Completion:
Last Updated: May 16, 2014
Last Verified: March 2013