<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/NCT02239523</url>
  </required_header>
  <id_info>
    <org_study_id>201497CTIL</org_study_id>
    <nct_id>NCT02239523</nct_id>
  </id_info>
  <brief_title>Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis</brief_title>
  <official_title>Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients who present with fragility fractures are consistently under-evaluated and&#xD;
      under-treated for underlying osteoporosis. This point of care represents a lost opportunity&#xD;
      to prevent future fractures. The medical field treats the fracture as if the fall is the&#xD;
      problem, but bone quality is the real problem. Studies have consistently shown that the&#xD;
      recommendations of the International Osteoporosis Foundation and World Health Organization&#xD;
      are not being followed. Orthopedics treats the patients for their fractures and primary care&#xD;
      physicians focus on general health but no one is taking responsibility for bone health.&#xD;
      Strategies to convince primary care to assume care have not succeeded. On the other hand,&#xD;
      strategies where orthopedics takes some responsibility have shown success. This prospective&#xD;
      2-arm study will evaluate the success of effort by an academic orthopedic department in&#xD;
      osteoporosis evaluation and treatment. We hypothesize that with greater effort by the&#xD;
      orthopedic department, the better the adherence to standards of care. A cost benefit analysis&#xD;
      will be made in parallel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who present to the orthopedic department in a level I trauma center will be&#xD;
      prospectively randomized into one of two groups:&#xD;
&#xD;
      Letter Group: At time of discharge, patients will be sent home with a discharge letter that&#xD;
      includes standard recommendations for evaluation and treatment. They will be asked to give&#xD;
      the letter to their primary care physician.&#xD;
&#xD;
      Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet&#xD;
      with explaining osteoporosis and the importance of treatment. The orthopedic department will&#xD;
      perform a bone density testing (DEXA). They will be given a letter with a specific medication&#xD;
      recommendation based on a protocol determined by our endocrinology department. They will be&#xD;
      asked to give both DEXA and medication recommendation to their primary care doctor to&#xD;
      initiate treatment. Finally, a research assistant will contact the patient monthly to&#xD;
      encourage them to start treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with osteoporosis that are appropriately treated</measure>
    <time_frame>Determination of proper treatment will be made at 4 months after the fracture.</time_frame>
    <description>Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who undergo DEXA scan.</measure>
    <time_frame>Evaluation will be made 4 months after the initial fracture event.</time_frame>
    <description>Whether or not the patients received the medication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost benefit analysis</measure>
    <time_frame>Evaluation will be made at time of discharge and up to 4 months from the fracture event.</time_frame>
    <description>Cost analysis will be made for each patient during the hospitalization and for 3 months after the fracture to capture complications related to the initial event.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Osteoporotic Fracture</condition>
  <arm_group>
    <arm_group_label>Letter Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given a pamphlet about osteoporosis and importance of treatment, have a bone density test (DEXA) arranged, be given a specific medication recommendation and monthly followup phone calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Letter Group</intervention_name>
    <description>At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.</description>
    <arm_group_label>Letter Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intervention Group</intervention_name>
    <description>The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Intervention</other_name>
    <other_name>Dual-energy X-ray absorptiometry</other_name>
    <other_name>Bone density scan</other_name>
    <other_name>Bisphosphonate</other_name>
    <other_name>Prolia</other_name>
    <other_name>Denosumab</other_name>
    <other_name>Forteo</other_name>
    <other_name>Teriparatide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients over age 50 with fragility fracture defined as a fall from standing or&#xD;
             walking position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic cancer&#xD;
&#xD;
          -  Known metabolic bone disease&#xD;
&#xD;
          -  End-of-life care&#xD;
&#xD;
          -  Inability to provide consent&#xD;
&#xD;
          -  Known MRSA carriers&#xD;
&#xD;
          -  Fractures of the trochanter alone, shaft or peri-prosthetic fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gershon Zinger, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center, Jerusalem Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.</citation>
    <PMID>18451385</PMID>
  </reference>
  <reference>
    <citation>Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to &quot;own the bone&quot;. J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.</citation>
    <PMID>21915530</PMID>
  </reference>
  <reference>
    <citation>Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.</citation>
    <PMID>15634808</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pathologic fracture</keyword>
  <keyword>Insufficiency fracture</keyword>
  <keyword>Secondary fracture</keyword>
  <keyword>Fracture with bone fragility</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Bone loss</keyword>
  <keyword>Osteopenia</keyword>
  <keyword>Metabolic Bone Disease</keyword>
  <keyword>Fragility fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Osteoporotic Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Denosumab</mesh_term>
    <mesh_term>Teriparatide</mesh_term>
    <mesh_term>Diphosphonates</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/NCT02239523
org study id: 201497CTIL
nct id: NCT02239523
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients who present with fragility fractures are consistently under-evaluated and
      under-treated for underlying osteoporosis. This point of care represents a lost opportunity
      to prevent future fractures. The medical field treats the fracture as if the fall is the
      problem, but bone quality is the real problem. Studies have consistently shown that the
      recommendations of the International Osteoporosis Foundation and World Health Organization
      are not being followed. Orthopedics treats the patients for their fractures and primary care
      physicians focus on general health but no one is taking responsibility for bone health.
      Strategies to convince primary care to assume care have not succeeded. On the other hand,
      strategies where orthopedics takes some responsibility have shown success. This prospective
      2-arm study will evaluate the success of effort by an academic orthopedic department in
      osteoporosis evaluation and treatment. We hypothesize that with greater effort by the
      orthopedic department, the better the adherence to standards of care. A cost benefit analysis
      will be made in parallel.
Patients who present to the orthopedic department in a level I trauma center will be
      prospectively randomized into one of two groups:

      Letter Group: At time of discharge, patients will be sent home with a discharge letter that
      includes standard recommendations for evaluation and treatment. They will be asked to give
      the letter to their primary care physician.

      Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet
      with explaining osteoporosis and the importance of treatment. The orthopedic department will
      perform a bone density testing (DEXA). They will be given a letter with a specific medication
      recommendation based on a protocol determined by our endocrinology department. They will be
      asked to give both DEXA and medication recommendation to their primary care doctor to
      initiate treatment. Finally, a research assistant will contact the patient monthly to
      encourage them to start treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of patients with osteoporosis that are appropriately treated
time frame: Determination of proper treatment will be made at 4 months after the fracture.
description: Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.
measure: Percentage of patients who undergo DEXA scan.
time frame: Evaluation will be made 4 months after the initial fracture event.
description: Whether or not the patients received the medication
measure: Cost benefit analysis
time frame: Evaluation will be made at time of discharge and up to 4 months from the fracture event.
description: Cost analysis will be made for each patient during the hospitalization and for 3 months after the fracture to capture complications related to the initial event.
arm group label: Letter Group
arm group type: Active Comparator
description: Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.
arm group label: Intervention Group
arm group type: Experimental
description: Patients will be given a pamphlet about osteoporosis and importance of treatment, have a bone density test (DEXA) arranged, be given a specific medication recommendation and monthly followup phone calls.
intervention type: Procedure
intervention name: Letter Group
description: At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.
arm group label: Letter Group
intervention type: Procedure
intervention name: Intervention Group
description: The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.
arm group label: Intervention Group
other name: Intervention
other name: Dual-energy X-ray absorptiometry
other name: Bone density scan
other name: Bisphosphonate
other name: Prolia
other name: Denosumab
other name: Forteo
other name: Teriparatide
criteria: 
gender: All
minimum age: 50 Years
maximum age: 120 Years
healthy volunteers: No
last name: Gershon Zinger, MD MS
role: Principal Investigator
affiliation: Shaare Zedek Medical Center, Jerusalem Israel
facility: 
country: Israel
citation: Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.
PMID: 18451385
citation: Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone". J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.
PMID: 21915530
citation: Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.
PMID: 15634808
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Fractures, Bone
mesh term: Osteoporotic Fractures
mesh term: Denosumab
mesh term: Teriparatide
mesh term: Diphosphonates