<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675089</url>
  </required_header>
  <id_info>
    <org_study_id>0776/11</org_study_id>
    <secondary_id>2011/22962-3</secondary_id>
    <nct_id>NCT01675089</nct_id>
  </id_info>
  <brief_title>Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation</brief_title>
  <official_title>A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether zolendronic acid, a third generation&#xD;
      bisphosphonate, is effective in preventing bone loss in the first year after kidney&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the treatment of osteoporosis in the general population, a number of drugs reduce BMD&#xD;
      (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates&#xD;
      improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women.&#xD;
      Because of lack of data on safety and an increased risk of adverse effects, the use of these&#xD;
      drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH&#xD;
      or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD&#xD;
      stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate&#xD;
      treatment after kidney transplantation has been examined; however, histomorphometric and&#xD;
      fracture rate reduction data are lacking.&#xD;
&#xD;
      The purpose of this study is to determine whether zolendronic acid, a third generation&#xD;
      bisphosphonate, is effective in preventing bone loss in the first year after kidney&#xD;
      transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in bone turnover</measure>
    <time_frame>1 year</time_frame>
    <description>Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone microarchitecture</measure>
    <time_frame>1 year</time_frame>
    <description>Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Bone Mineral Density</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Renal Osteodystrophy</condition>
  <arm_group>
    <arm_group_label>Zoledronic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic acid</intervention_name>
    <description>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.</description>
    <arm_group_label>Zoledronic acid</arm_group_label>
    <other_name>Aclasta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult kidney transplant recipients who were stable perioperative and able to&#xD;
             return for regular follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glomerular filtration rate &lt; 30 ml/min/1.73m² one week after transplantation&#xD;
&#xD;
          -  Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elias David-Neto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>May 16, 2014</last_update_submitted>
  <last_update_submitted_qc>May 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone disease</keyword>
  <keyword>kidney transplantation</keyword>
  <keyword>bisphosphonates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Kidney Disease-Mineral and Bone Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zoledronic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675089
org study id: 0776/11
secondary id: 2011/22962-3
nct id: NCT01675089
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in bone turnover
time frame: 1 year
description: Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.
measure: Bone microarchitecture
time frame: 1 year
description: Bone microarchitecture will be examined by high-resolution peripheral quantitative computed tomography at the time of transplant and after 12 months.
measure: Changes in Bone Mineral Density
time frame: 1 year
description: 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.
arm group label: Zoledronic acid
arm group type: Experimental
description: Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.
arm group label: Control
arm group type: No Intervention
description: 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.
intervention type: Drug
intervention name: Zoledronic acid
description: 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.
arm group label: Zoledronic acid
other name: Aclasta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elias David-Neto, MD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Chronic Kidney Disease-Mineral and Bone Disorder
mesh term: Zoledronic Acid