<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/NCT03301285</url>
  </required_header>
  <id_info>
    <org_study_id>PSS2016/ZOMETA-FEILLET/VS</org_study_id>
    <nct_id>NCT03301285</nct_id>
  </id_info>
  <brief_title>Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities</brief_title>
  <acronym>ZOMETA</acronym>
  <official_title>Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone&#xD;
      density in children with osteoporosis caused by multiple disabilities.&#xD;
&#xD;
      Secondary purposes are:&#xD;
&#xD;
        1. Description of child population with osteoporosis in the context of motor impairment in&#xD;
           Lorraine region&#xD;
&#xD;
        2. Description of osteoporosis stage (level of bone mineralization and clinical&#xD;
           consequences) in children with multiple disabilities&#xD;
&#xD;
        3. Description of current osteoporosis preventive care&#xD;
&#xD;
        4. Description of risk factors associated to bone status (drugs)&#xD;
&#xD;
        5. Evaluation of zoledronic acid treatment on fracture numbers&#xD;
&#xD;
        6. Evaluation of zoledronic acid on phosphocalcic profile&#xD;
&#xD;
        7. Description of side effects of zoledronic acid in this indication&#xD;
&#xD;
        8. Description of treatment effects in the sub-population of children with Rett syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (before start of zoledronic acid treatment) lumbar bone density</measure>
    <time_frame>through study completion, 4 years</time_frame>
    <description>reported in Z-score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of bone fractures</measure>
    <time_frame>Until baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term administration of vitamin/calcium supplement or not</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administration of drugs or not</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of fractures after the start of zoledronic acid treatment</measure>
    <time_frame>through study completion, 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline phosphocalcic profile evaluation</measure>
    <time_frame>through study completion, 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of side effects</measure>
    <time_frame>through study completion, 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment</measure>
    <time_frame>1 year from baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Multiple Disability</condition>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Children with osteoporosis associated to multiple disabilities</arm_group_label>
    <description>Treated with zoledronic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic Acid</intervention_name>
    <description>Treatment of osteoporosis</description>
    <arm_group_label>Children with osteoporosis associated to multiple disabilities</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All children followed for osteoporosis associated to multiple disabilities, treated with&#xD;
        zoledronic acid, followed at pediatric department of Nancy hospital, between 01/01/2012 and&#xD;
        11/01/2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non refusal of parents of participation of their child to the study&#xD;
&#xD;
          -  Patients followed for multiple disabilities&#xD;
&#xD;
          -  Osteoporosis: lumbar osteodensitometry z-score &lt;-2.5 SD associated or not to&#xD;
             pathologic fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)&#xD;
&#xD;
          -  Absence of multiple disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital - CHRU de Nancy</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03301285
org study id: PSS2016/ZOMETA-FEILLET/VS
nct id: NCT03301285
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone
      density in children with osteoporosis caused by multiple disabilities.

      Secondary purposes are:

        1. Description of child population with osteoporosis in the context of motor impairment in
           Lorraine region

        2. Description of osteoporosis stage (level of bone mineralization and clinical
           consequences) in children with multiple disabilities

        3. Description of current osteoporosis preventive care

        4. Description of risk factors associated to bone status (drugs)

        5. Evaluation of zoledronic acid treatment on fracture numbers

        6. Evaluation of zoledronic acid on phosphocalcic profile

        7. Description of side effects of zoledronic acid in this indication

        8. Description of treatment effects in the sub-population of children with Rett syndrome.
observational model: Case-Crossover
time perspective: Retrospective
measure: Change from baseline (before start of zoledronic acid treatment) lumbar bone density
time frame: through study completion, 4 years
description: reported in Z-score
measure: Age
time frame: Baseline
measure: Sex
time frame: Baseline
measure: Height
time frame: Baseline
measure: Weight
time frame: Baseline
measure: Occurrence of bone fractures
time frame: Until baseline
measure: Long-term administration of vitamin/calcium supplement or not
time frame: baseline
measure: Administration of drugs or not
time frame: baseline
measure: Number of fractures after the start of zoledronic acid treatment
time frame: through study completion, 4 years
measure: Change from baseline phosphocalcic profile evaluation
time frame: through study completion, 4 years
measure: Frequency of side effects
time frame: through study completion, 4 years
measure: Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment
time frame: 1 year from baseline
arm group label: Children with osteoporosis associated to multiple disabilities
description: Treated with zoledronic acid
intervention type: Drug
intervention name: Zoledronic Acid
description: Treatment of osteoporosis
arm group label: Children with osteoporosis associated to multiple disabilities
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Zoledronic Acid
sharing ipd: No