<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/NCT01731535</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0437</org_study_id>
    <nct_id>NCT01731535</nct_id>
  </id_info>
  <brief_title>Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.</brief_title>
  <official_title>Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dose and duration of bisphosphonate therapy will increase the likelihood that patients&#xD;
      experience delayed healing of non-union fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We intend to review the UWHealth patient database to identify individuals with delayed or&#xD;
      nonunion fractures. Subsequently, we will collect associated medical information related to&#xD;
      fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type&#xD;
      and location of fracture, time to complete union, other treatment needed for nonunion etc.&#xD;
      With this information, we will evaluate the risk of delayed and nonunion fractures in&#xD;
      patients previously receiving bisphosphonate treatment compared to a normal population. We&#xD;
      also will investigate other potential causes of delayed or nonunion fractures in this&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    It was a project initiated by a trainee but did not progress to subject accrual.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients with delayed healing or non-union fractures with prior bisphosphonate use</measure>
    <time_frame>01/01/2000 - 12/31/2011</time_frame>
    <description>This variable will be generated by reviewing diagnosis codes from patients seen at the University of Wisconsin Hospital and Clinics during the time period identified above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.</measure>
    <time_frame>1/1/2000-12-31-2012</time_frame>
    <description>Patients with non-union or delayed healing fractures obtaining care at the University of Wisconsin Hospital or Clinics will have a medical record review conducted.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-union or Delayed Healing Fractures</condition>
  <arm_group>
    <arm_group_label>Prior bisphosphonate users</arm_group_label>
    <description>Patients with record of using bisphosphonate medication</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women older than 60 years old with delayed or nonunion low trauma fracture beween&#xD;
        01/01/2000 - 12/31/2011.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women older than 60 years old with delayed or nonunion low trauma fracture&#xD;
             between 01/01/2000 - 12/31/2011.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Binkley, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>October 9, 2015</last_update_submitted>
  <last_update_submitted_qc>October 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_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/NCT01731535
org study id: 2012-0437
nct id: NCT01731535
lead sponsor: 
has dmc: No
Dose and duration of bisphosphonate therapy will increase the likelihood that patients
      experience delayed healing of non-union fractures.
We intend to review the UWHealth patient database to identify individuals with delayed or
      nonunion fractures. Subsequently, we will collect associated medical information related to
      fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type
      and location of fracture, time to complete union, other treatment needed for nonunion etc.
      With this information, we will evaluate the risk of delayed and nonunion fractures in
      patients previously receiving bisphosphonate treatment compared to a normal population. We
      also will investigate other potential causes of delayed or nonunion fractures in this
      population.
time perspective: Retrospective
measure: The number of patients with delayed healing or non-union fractures with prior bisphosphonate use
time frame: 01/01/2000 - 12/31/2011
description: This variable will be generated by reviewing diagnosis codes from patients seen at the University of Wisconsin Hospital and Clinics during the time period identified above.
measure: Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.
time frame: 1/1/2000-12-31-2012
description: Patients with non-union or delayed healing fractures obtaining care at the University of Wisconsin Hospital or Clinics will have a medical record review conducted.
arm group label: Prior bisphosphonate users
description: Patients with record of using bisphosphonate medication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Binkley, MD
role: Study Director
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone