<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/NCT01702415</url>
  </required_header>
  <id_info>
    <org_study_id>P01612</org_study_id>
    <nct_id>NCT01702415</nct_id>
  </id_info>
  <brief_title>Zoledronic Acid in Cystic Fibrosis</brief_title>
  <acronym>IZAC</acronym>
  <official_title>Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Papworth Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Papworth Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.&#xD;
&#xD;
      Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF);&#xD;
      they have an increased rate of bone fractures in comparison to the general population. CF&#xD;
      patients start to lose bone density in adolescence/early adulthood due to an imbalance in&#xD;
      bone breakdown and formation. Predicted survival for patients with CF has increased from 16&#xD;
      years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities&#xD;
      associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous&#xD;
      bisphophosphonates are known to increase bone density in CF; the current licensed oral&#xD;
      preparations require daily or weekly dosing which are difficult to maintain. Zoledronate,&#xD;
      which is licensed for use, is administered intravenously once a year which should be easier&#xD;
      to administer. The current evidence relates to its use in other disease groups e.g.&#xD;
      glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain&#xD;
      its efficacy in cystic fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone density</measure>
    <time_frame>12 months</time_frame>
    <description>Bone density measure by DEXA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of zoledronic acid on the number of bone fractures</measure>
    <time_frame>12 months</time_frame>
    <description>Bone fractures</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Bone pain</measure>
    <time_frame>12 months</time_frame>
    <description>Frequency and severity of bone pain as a possible side effect of zoledronic acid</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zoledronic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active IMP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic acid</intervention_name>
    <description>Single dose, intravenous solution 5mg</description>
    <arm_group_label>Zoledronic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cystic fibrosis&#xD;
&#xD;
          -  Aged at least 18 years&#xD;
&#xD;
          -  Bone mineral density score of -1.5 or less at lumbar spine or total hip&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous solid organ transplant&#xD;
&#xD;
          -  on solid organ transplant waiting list&#xD;
&#xD;
          -  Long trem oral glucocorticosteroids&#xD;
&#xD;
          -  CRP &gt;20mg on day of randomisation&#xD;
&#xD;
          -  Hypocalcaemia&#xD;
&#xD;
          -  Poor dental hygiene&#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>Charles Dr Haworth, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Papworth Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Papworth Hospital NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB23 3RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic fibrosis</keyword>
  <keyword>Bone density</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT01702415
org study id: P01612
nct id: NCT01702415
lead sponsor: 
collaborator: 
has dmc: Yes
Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.

      Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF);
      they have an increased rate of bone fractures in comparison to the general population. CF
      patients start to lose bone density in adolescence/early adulthood due to an imbalance in
      bone breakdown and formation. Predicted survival for patients with CF has increased from 16
      years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities
      associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous
      bisphophosphonates are known to increase bone density in CF; the current licensed oral
      preparations require daily or weekly dosing which are difficult to maintain. Zoledronate,
      which is licensed for use, is administered intravenously once a year which should be easier
      to administer. The current evidence relates to its use in other disease groups e.g.
      glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain
      its efficacy in cystic fibrosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Bone density
time frame: 12 months
description: Bone density measure by DEXA
measure: Effect of zoledronic acid on the number of bone fractures
time frame: 12 months
description: Bone fractures
measure: Bone pain
time frame: 12 months
description: Frequency and severity of bone pain as a possible side effect of zoledronic acid
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: Zoledronic acid
arm group type: Experimental
description: Active IMP
intervention type: Drug
intervention name: Zoledronic acid
description: Single dose, intravenous solution 5mg
arm group label: Zoledronic acid
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Dr Haworth, FRCP
role: Principal Investigator
affiliation: Papworth Hospital NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Zoledronic Acid