xml: <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/NCT05971173</url>
    </required_header>
    <id_info>
      <org_study_id>HSC20230182H</org_study_id>
      <secondary_id>5P30AG044271</secondary_id>
      <nct_id>NCT05971173</nct_id>
    </id_info>
    <brief_title>Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery</brief_title>
    <official_title>Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center at San Antonio</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center at San Antonio</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall objective of this pilot study is to test a comprehensive nutritional intervention&#xD;
        in elderly patients diagnosed with hip fracture, which the study team believe will reduce&#xD;
        functional decline, morbidity and mortality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon&#xD;
        with extensive experience in the care of older adults with hip fractures. In addition, the&#xD;
        multidisciplinary study team includes a research health scientist with vast experience in&#xD;
        nutrition, preventive health, and gerontology. The study team will also be supported by a&#xD;
        physical therapist and researcher in the field of rehabilitation of older adults with&#xD;
        musculoskeletal disorders. Furthermore, an occupational therapist with expertise in&#xD;
        rehabilitation science, conduct of pilot studies, and analysis of interview data will play an&#xD;
        important role in this study. Moreover, the statistical analyses will be performed by an&#xD;
        expert statistical consultant from our institution, who will be reimbursed on a fee for&#xD;
        service basis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of surgical complications at 26 weeks</measure>
      <time_frame>26 weeks (post surgery)</time_frame>
      <description>Number of subjects that experienced any complications post surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hospital Readmissions</measure>
      <time_frame>26 weeks (post surgery)</time_frame>
      <description>Number of hospital re-admissions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary fractures</measure>
      <time_frame>26 weeks (post surgery)</time_frame>
      <description>Number of secondary fractures that occurred post surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip strength</measure>
      <time_frame>Baseline to 26 weeks</time_frame>
      <description>Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Survey (Short-form 36 Health (SF-36))</measure>
      <time_frame>Baseline to 26 weeks</time_frame>
      <description>Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hip Fractures</condition>
    <arm_group>
      <arm_group_label>Nutritional Supplements</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Juven and Centrum Silver 50+ will be administered to this group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard of care procedures</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Juven</intervention_name>
      <description>Nutritional supplements</description>
      <arm_group_label>Nutritional Supplements</arm_group_label>
      <other_name>Conditionally essential amino acids</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Centrum Silver 50+</intervention_name>
      <description>Over the counter nutritional supplement</description>
      <arm_group_label>Nutritional Supplements</arm_group_label>
      <other_name>Multivitamin/multimineral</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form&#xD;
  &#xD;
            2. Male or female, aged 65-89 years&#xD;
  &#xD;
            3. Closed fracture of the proximal femur including the anatomic areas of femoral neck,&#xD;
               intertrochanteric and subtrochanteric region&#xD;
  &#xD;
            4. Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per&#xD;
               orthopaedic surgeon&#xD;
  &#xD;
            5. Ability to take oral medication and be willing to adhere to the study drug regimen and&#xD;
               to the nutritional guidance provided by nutritional experts.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with open fractures&#xD;
  &#xD;
            2. Surgical treatment other than surgical fixation or arthroplasty, such as proximal&#xD;
               femur resection&#xD;
  &#xD;
            3. Known allergic reactions to components of the study drugs or who do not tolerate oral&#xD;
               nutritional supplementation (e.g. total parenteral nutrition or food allergies)&#xD;
  &#xD;
            4. Decisional impairment&#xD;
  &#xD;
            5. Prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Boris Zelle, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas Health Science Center San Antonio</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Boris Zelle, MD</last_name>
      <phone>210-743-4104</phone>
      <email>zelle@uthscsa.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ashley Bandfield</last_name>
      <phone>210-450-9096</phone>
      <email>bandfield@uthscsa.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Health System</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Boris Zelle</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>UT Health San Antonio Department of Orthopedics</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>210-216-5439</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
      <investigator_full_name>Boris Zelle</investigator_full_name>
      <investigator_title>Vice Chair of Research, Chief of Orthopaedic Trauma</investigator_title>
    </responsible_party>
    <keyword>Older adults</keyword>
    <keyword>Hip surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected deidentified IPD, that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>At the time of publication in a peer reviewed journal</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971173
  org study id: HSC20230182H
  secondary id: 5P30AG044271
  nct id: NCT05971173
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The overall objective of this pilot study is to test a comprehensive nutritional intervention
        in elderly patients diagnosed with hip fracture, which the study team believe will reduce
        functional decline, morbidity and mortality.
  This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon
        with extensive experience in the care of older adults with hip fractures. In addition, the
        multidisciplinary study team includes a research health scientist with vast experience in
        nutrition, preventive health, and gerontology. The study team will also be supported by a
        physical therapist and researcher in the field of rehabilitation of older adults with
        musculoskeletal disorders. Furthermore, an occupational therapist with expertise in
        rehabilitation science, conduct of pilot studies, and analysis of interview data will play an
        important role in this study. Moreover, the statistical analyses will be performed by an
        expert statistical consultant from our institution, who will be reimbursed on a fee for
        service basis.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Assessment of surgical complications at 26 weeks
  time frame: 26 weeks (post surgery)
  description: Number of subjects that experienced any complications post surgery
  measure: Hospital Readmissions
  time frame: 26 weeks (post surgery)
  description: Number of hospital re-admissions
  measure: Secondary fractures
  time frame: 26 weeks (post surgery)
  description: Number of secondary fractures that occurred post surgery
  measure: Grip strength
  time frame: Baseline to 26 weeks
  description: Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds
  measure: Quality of Life Survey (Short-form 36 Health (SF-36))
  time frame: Baseline to 26 weeks
  description: Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
  arm group label: Nutritional Supplements
  arm group type: Experimental
  description: Juven and Centrum Silver 50+ will be administered to this group
  arm group label: Control
  arm group type: No Intervention
  description: Standard of care procedures
  intervention type: Drug
  intervention name: Juven
  description: Nutritional supplements
  arm group label: Nutritional Supplements
  other name: Conditionally essential amino acids
  intervention type: Drug
  intervention name: Centrum Silver 50+
  description: Over the counter nutritional supplement
  arm group label: Nutritional Supplements
  other name: Multivitamin/multimineral
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Boris Zelle, MD
  role: Principal Investigator
  affiliation: University of Texas Health Science Center San Antonio
  last name: Boris Zelle, MD
  phone: 210-743-4104
  email: zelle@uthscsa.edu
  last name: Ashley Bandfield
  phone: 210-450-9096
  email: bandfield@uthscsa.edu
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center at San Antonio
  investigator full name: Boris Zelle
  investigator title: Vice Chair of Research, Chief of Orthopaedic Trauma
  mesh term: Fractures, Bone
  mesh term: Hip Fractures
  sharing ipd: Yes
  ipd description: All collected deidentified IPD, that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: At the time of publication in a peer reviewed journal