<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/NCT02223572</url>
  </required_header>
  <id_info>
    <org_study_id>HipFracture2014</org_study_id>
    <nct_id>NCT02223572</nct_id>
  </id_info>
  <brief_title>Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture</brief_title>
  <official_title>Secondary Fracture Prevention in Patients Hospitalized for Hip Fracture: Adding the Metabolic Treatment to the Surgical One.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>pninarotman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to its prevalence worldwide, osteoporosis is considered a serious public health concern.&#xD;
      The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US&#xD;
      only.&#xD;
&#xD;
      Hip fracture is associated with serious disability and excess mortality. Studies have shown&#xD;
      that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased&#xD;
      risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already&#xD;
      sustained a fracture in the past 4 years (In average). These data indicate the major&#xD;
      opportunity afforded by secondary fracture prevention strategies.&#xD;
&#xD;
      By responding to the first fracture, we can reduce the incidence of second and subsequent&#xD;
      fractures. However, even after longer medical follow-up according to regular standard of&#xD;
      care, medical treatment and rehabilitation, the medical system has been unable to translate&#xD;
      the eminent risk into an effective preventive treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objectives:&#xD;
&#xD;
        -  To create a treatment, follow up and rehabilitation protocol for patients who suffered&#xD;
           from a hip fracture, in order to prevent a secondary fracture.&#xD;
&#xD;
        -  To demonstrate that a combined treatment from the Hip Fractures Clinic as well as the&#xD;
           regular standard treatment and rehabilitation suggested by the Bone Health Clinic (both&#xD;
           in addition to standard medication prescribed for osteoporosis) will result in a&#xD;
           significant reduction of second and subsequent fractures.&#xD;
&#xD;
      Study Protocol:&#xD;
&#xD;
        1. The study protocol will begin after the patients, who have been admitted with a primary&#xD;
           hip fracture (of osteoporotic nature), were surgically treated (as customary standard of&#xD;
           care).&#xD;
&#xD;
        2. According to hospitalization standard protocol, the patients will be treated with&#xD;
           vitamin D and calcium. For the first month the patient will be given a loading dose of&#xD;
           70,000 units. For the next months the patients will receive 50,000-80,000 units per&#xD;
           month.&#xD;
&#xD;
           In addition, the patient will be treated with Calcium Pills (Caltrate TAB 600mg, once a&#xD;
           day)&#xD;
&#xD;
        3. In addition to the clinical customary monitoring tests performed during the&#xD;
           hospitalization, Biomarkers and safety assessment will be taken:&#xD;
&#xD;
             1. Vitamin D&#xD;
&#xD;
             2. Bone Markers - Bone markers will be taken three days after the patient was&#xD;
                admitted, and one more time six months later (as part of follow up visit).&#xD;
&#xD;
        4. Follow up visits after hospitalization due to surgery for primary hip fracture.&#xD;
&#xD;
             1. Follow up visits at the Hip Fracture Clinic will occur in intervals of: six weeks,&#xD;
                3 months, 6 months and a year, since the patient had been released from&#xD;
                hospitalization. At follow up visit, the patient will be assessed for physical&#xD;
                examination, hip X-ray and the rehabilitation progression Questionnaire (HHS).&#xD;
&#xD;
             2. Follow up visits at the Bone Health Clinic will occur between 6 weeks to 3 months&#xD;
                since the patient had been released from hospitalization (as part of regular&#xD;
                standard of care).&#xD;
&#xD;
             3. A 3cc Serum sample will be taken with the purpose to serve on future studies and&#xD;
                examine new markers such as bone markers SCLEROSTIN. There will be no further use&#xD;
                of these samples. The samples will remain in deep freeze temperature (C˚70-).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduce number of incidents of secondary hip fracture.</measure>
    <time_frame>1 year and 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Osteoporotic Fractures</condition>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>osteoporotic hip fracture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hip Xray</intervention_name>
    <arm_group_label>osteoporotic hip fracture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years old&#xD;
&#xD;
          -  Patients diagnosed with low energy osteoporotic hip fracture, and was treated under&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not diagnosed with osteoporosis.&#xD;
&#xD;
          -  Patients diagnosed with high energy osteoporotic hip fracture.&#xD;
&#xD;
          -  Patients that suffered from Multiple Trauma.&#xD;
&#xD;
          -  Patients diagnosed with Metabolic diseases or Genetic diseases.&#xD;
&#xD;
          -  Pregnant women&#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>Eyal Yaacobi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pnina Rotman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pnina Rotman, MD</last_name>
    <phone>+972-9-7472671</phone>
    <email>Pnina.Rotman@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eyal Yaacobi, MD</last_name>
    <phone>+972-3-9385700</phone>
    <email>Eyal.Yaacobi@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Eyal Yaacobi, MD</last_name>
      <phone>972-3-9385700</phone>
      <email>Eyal.Yaacobi@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Pnina Rotman, MD</last_name>
      <phone>972-9-7472671</phone>
      <email>Pnina.Rotman@clalit.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>pninarotman</investigator_full_name>
    <investigator_title>Depart. of Medicine 'E' Deputy Head</investigator_title>
  </responsible_party>
  <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>Hip Fractures</mesh_term>
    <mesh_term>Osteoporotic Fractures</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/NCT02223572
org study id: HipFracture2014
nct id: NCT02223572
lead sponsor: 
collaborator: 
has dmc: No
Due to its prevalence worldwide, osteoporosis is considered a serious public health concern.
      The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US
      only.

      Hip fracture is associated with serious disability and excess mortality. Studies have shown
      that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased
      risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already
      sustained a fracture in the past 4 years (In average). These data indicate the major
      opportunity afforded by secondary fracture prevention strategies.

      By responding to the first fracture, we can reduce the incidence of second and subsequent
      fractures. However, even after longer medical follow-up according to regular standard of
      care, medical treatment and rehabilitation, the medical system has been unable to translate
      the eminent risk into an effective preventive treatment.
Study Objectives:

        -  To create a treatment, follow up and rehabilitation protocol for patients who suffered
           from a hip fracture, in order to prevent a secondary fracture.

        -  To demonstrate that a combined treatment from the Hip Fractures Clinic as well as the
           regular standard treatment and rehabilitation suggested by the Bone Health Clinic (both
           in addition to standard medication prescribed for osteoporosis) will result in a
           significant reduction of second and subsequent fractures.

      Study Protocol:

        1. The study protocol will begin after the patients, who have been admitted with a primary
           hip fracture (of osteoporotic nature), were surgically treated (as customary standard of
           care).

        2. According to hospitalization standard protocol, the patients will be treated with
           vitamin D and calcium. For the first month the patient will be given a loading dose of
           70,000 units. For the next months the patients will receive 50,000-80,000 units per
           month.

           In addition, the patient will be treated with Calcium Pills (Caltrate TAB 600mg, once a
           day)

        3. In addition to the clinical customary monitoring tests performed during the
           hospitalization, Biomarkers and safety assessment will be taken:

             1. Vitamin D

             2. Bone Markers - Bone markers will be taken three days after the patient was
                admitted, and one more time six months later (as part of follow up visit).

        4. Follow up visits after hospitalization due to surgery for primary hip fracture.

             1. Follow up visits at the Hip Fracture Clinic will occur in intervals of: six weeks,
                3 months, 6 months and a year, since the patient had been released from
                hospitalization. At follow up visit, the patient will be assessed for physical
                examination, hip X-ray and the rehabilitation progression Questionnaire (HHS).

             2. Follow up visits at the Bone Health Clinic will occur between 6 weeks to 3 months
                since the patient had been released from hospitalization (as part of regular
                standard of care).

             3. A 3cc Serum sample will be taken with the purpose to serve on future studies and
                examine new markers such as bone markers SCLEROSTIN. There will be no further use
                of these samples. The samples will remain in deep freeze temperature (C˚70-).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reduce number of incidents of secondary hip fracture.
time frame: 1 year and 6 months
arm group label: osteoporotic hip fracture
arm group type: Experimental
intervention type: Radiation
intervention name: hip Xray
arm group label: osteoporotic hip fracture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eyal Yaacobi, M.D.
role: Principal Investigator
affiliation: Meir Medical Center
last name: Pnina Rotman, MD
role: Principal Investigator
affiliation: Meir Medical Center
last name: Pnina Rotman, MD
phone: +972-9-7472671
email: Pnina.Rotman@clalit.org.il
last name: Eyal Yaacobi, MD
phone: +972-3-9385700
email: Eyal.Yaacobi@clalit.org.il
facility: 
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Meir Medical Center
investigator full name: pninarotman
investigator title: Depart. of Medicine 'E' Deputy Head
mesh term: Osteoporosis
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Osteoporotic Fractures