<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/NCT03295981</url>
  </required_header>
  <id_info>
    <org_study_id>28229</org_study_id>
    <nct_id>NCT03295981</nct_id>
  </id_info>
  <brief_title>Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone</brief_title>
  <official_title>Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthopedic Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the clinical study is to investigate whether the local delivery of&#xD;
      bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone&#xD;
      coming back to the same location. The hypothesis is that the local administration of&#xD;
      bisphosphonate will decrease the rate of the tumor returning compared to traditional&#xD;
      aggressive surgical removal of the tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the clinical study is to investigate whether the local delivery of&#xD;
      bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local&#xD;
      recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether&#xD;
      bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function,&#xD;
      fever, or wound complications. The hypothesis is that the local administration of&#xD;
      bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive&#xD;
      intralesional curettage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The endpoint for patient participation will be local recurrence</measure>
    <time_frame>Followed for 2 years postoperatively for study end points</time_frame>
    <description>Local recurrence of giant cell tumor of bone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MSTS Score</measure>
    <time_frame>Followed for 2 years postoperatively for study end points</time_frame>
    <description>The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.</time_frame>
    <description>The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.</time_frame>
    <description>The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential bisphosphonate complications related to systemic administration</measure>
    <time_frame>Followed for 2 years postoperatively for study end points</time_frame>
    <description>Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Giant Cell Tumor of Bone</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bisphosphonate group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic Acid</intervention_name>
    <description>4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement</description>
    <arm_group_label>Bisphosphonate group</arm_group_label>
    <other_name>zoledronate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary benign GCT of bone&#xD;
&#xD;
          -  Lesion located in an extremity&#xD;
&#xD;
          -  Lesion amenable to reconstruction (intralesional curettage) defined as having at least&#xD;
             one intact column of bone after removal&#xD;
&#xD;
          -  No previous systemic bisphosphonate or denosumab therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent GCT of bone&#xD;
&#xD;
          -  Non-extremity location&#xD;
&#xD;
          -  Lesion too extensive for intralesional treatment, either due to bone loss, joint&#xD;
             invasion, or large soft tissue component&#xD;
&#xD;
          -  Children and pregnancy&#xD;
&#xD;
          -  Previous systemic bisphosphonate or denosumab therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Allison Gruender, RN</last_name>
    <phone>314-977-4106</phone>
    <email>allison.gruender@health.slu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marsha Steffen, RN</last_name>
    <phone>314-577-8904</phone>
    <email>marsha.steffen@health.slu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California - Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julian Dilley</last_name>
      <email>jedilley@indiana.edu</email>
    </contact>
    <investigator>
      <last_name>L.Daniel Wurtz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abigail Grothe</last_name>
      <email>abigail-grothe@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Benjamin Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon Bradshaw</last_name>
      <email>sbradshaw2@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Kyle Sweeney, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vaishali Laljani</last_name>
      <email>vparikh2@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Levin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Alisha Sodhi</last_name>
      <email>asodhi1@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Santiago Lozano Calderon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernanda Canizares</last_name>
      <email>maria.canizares@childrens.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Megan Anderson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katiri Wagner</last_name>
      <email>kwagner@bidmc.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Megan Anderson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Greenberg, MD</last_name>
      <phone>314-977-4147</phone>
      <email>david.greenberg@health.slu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Allison Gruender, RN</last_name>
      <phone>(314) 977-4106</phone>
      <email>allison.gruender@health.slu.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ariel Brotherton, MA</last_name>
      <email>abrother@wakehealth.edu</email>
    </contact>
    <investigator>
      <last_name>Cynthia Emory, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Keaney, MPH</last_name>
      <email>keaneyh@ccf.org</email>
    </contact>
    <contact_backup>
      <last_name>Kierstyn Hayden</last_name>
      <email>haydenk2@ccf.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lukas Nystrom, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathy Edge</last_name>
      <email>Kathy-edge@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Jeremy White, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Allegheny-Singer Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myles Forsyth</last_name>
      <email>myles.forsyth@ahn.org</email>
    </contact>
    <investigator>
      <last_name>Lisa Ercolano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadine Zablith</last_name>
      <email>nadine.zablith@muhc.mcgill.ca</email>
    </contact>
    <investigator>
      <last_name>Robert Turcotte, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>David Greenberg, MD;; Associate Professor</investigator_full_name>
    <investigator_title>Associate Professor Orthopaedic Surgery Saint Louis University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Giant Cell Tumors</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Giant Cell Tumor of Bone</mesh_term>
    <mesh_term>Recurrence</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/NCT03295981
org study id: 28229
nct id: NCT03295981
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of the clinical study is to investigate whether the local delivery of
      bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone
      coming back to the same location. The hypothesis is that the local administration of
      bisphosphonate will decrease the rate of the tumor returning compared to traditional
      aggressive surgical removal of the tumor.
The purpose of the clinical study is to investigate whether the local delivery of
      bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local
      recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether
      bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function,
      fever, or wound complications. The hypothesis is that the local administration of
      bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive
      intralesional curettage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
measure: The endpoint for patient participation will be local recurrence
time frame: Followed for 2 years postoperatively for study end points
description: Local recurrence of giant cell tumor of bone
measure: MSTS Score
time frame: Followed for 2 years postoperatively for study end points
description: The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
measure: Surgical site infection
time frame: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.
description: The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below.
measure: Wound healing
time frame: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.
description: The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues/concerns.
measure: Potential bisphosphonate complications related to systemic administration
time frame: Followed for 2 years postoperatively for study end points
description: Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw
arm group label: Control group
arm group type: No Intervention
description: The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.
arm group label: Bisphosphonate group
arm group type: Experimental
description: In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
intervention type: Drug
intervention name: Zoledronic Acid
description: 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
arm group label: Bisphosphonate group
other name: zoledronate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Allison Gruender, RN
phone: 314-977-4106
email: allison.gruender@health.slu.edu
last name: Marsha Steffen, RN
phone: 314-577-8904
email: marsha.steffen@health.slu.edu
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: David Greenberg, MD;; Associate Professor
investigator title: Associate Professor Orthopaedic Surgery Saint Louis University
mesh term: Giant Cell Tumors
mesh term: Bone Neoplasms
mesh term: Giant Cell Tumor of Bone
mesh term: Recurrence
mesh term: Zoledronic Acid
sharing ipd: No