Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

NCT ID: NCT01675089

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-05-31

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.

Conditions

Renal Osteodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zoledronic acid

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

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Aclasta

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elias David-Neto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2011/22962-3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0776/11

Identifier Type: -

Identifier Source: org_study_id