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Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01675089
First received: August 23, 2012
Last updated: May 16, 2014
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Renal Osteodystrophy
Drug: Zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Differences in bone turnover [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.


Secondary Outcome Measures:
  • Bone microarchitecture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid
Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.
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.
Other Name: Aclasta
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675089

Locations
Brazil
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Elias David-Neto, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01675089     History of Changes
Other Study ID Numbers: 0776/11, 2011/22962-3
Study First Received: August 23, 2012
Last Updated: May 16, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
bone disease
kidney transplantation
bisphosphonates

Additional relevant MeSH terms:
Renal Osteodystrophy
Avitaminosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Nutrition Disorders
Parathyroid Diseases
Rickets
Urologic Diseases
Vitamin D Deficiency
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014