Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675089
• Other study ID #: 0776/11
• Secondary ID: 2011/22962-3
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2012
• Last updated: May 16, 2014
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: March 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult kidney transplant recipients who were stable perioperative and able to return for regular follow-up

Exclusion Criteria:

• Glomerular filtration rate < 30 ml/min/1.73m² one week after transplantation

• Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in bone turnover	Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.	1 year	Yes
Secondary	Bone microarchitecture	Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months.	1 year	No
Secondary	Changes in Bone Mineral Density	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.	1 year	No