Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

NCT01675089 | Completed Phase 4 DMC

• 2 other identifiers: 0776/112011/22962-3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Osteodystrophy

Keywords

bone disease; kidney transplantation; bisphosphonates

Outcome Measures

Primary Outcomes (1)

• Differences in bone turnover

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

  1 year

Secondary Outcomes (2)

• Bone microarchitecture

  1 year

• Changes in Bone Mineral Density

  1 year

Study Arms (2)

Zoledronic acid

EXPERIMENTAL

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

Drug: Zoledronic acid

Control

NO INTERVENTION

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.

Interventions

Zoledronic acid 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.

Also known as: Aclasta

Zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Glomerular filtration rate \< 30 ml/min/1.73m² one week after transplantation
• Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Bone Diseases

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elias David-Neto, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 29, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 19, 2014

Record last verified: 2013-03

Locations

BR (1)