Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

Phase 4

Completed

• Conditions: Renal Osteodystrophy
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT01675089
• Lead Sponsor: University of Sao Paulo General Hospital

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 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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Status Verified: 2013-03
• Primary Completion: 2013-07
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid	Zoledronic acid	Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.

Primary Outcome Measures

Name	Time	Method
Differences in bone turnover	1 year	Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.

Secondary Outcome Measures

Name	Time	Method
Bone microarchitecture	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	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.

Trial Locations

Locations (1)

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil