<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/NCT03832088</url>
  </required_header>
  <id_info>
    <org_study_id>MedeniyetOP</org_study_id>
    <nct_id>NCT03832088</nct_id>
  </id_info>
  <brief_title>Sarcopenia And Balance In Postmenopausal Osteoporosis</brief_title>
  <official_title>Sarcopenia And Balance In Postmenopausal Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medeniyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</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>
      The study was performed on 53 postmenopausal osteoporosis patients who presented to our&#xD;
      osteoporosis outpatient clinic. Following written informed consent, patients were evaluated&#xD;
      for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group&#xD;
      on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle&#xD;
      strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of&#xD;
      walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference&#xD;
      for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale&#xD;
      (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other&#xD;
      clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within&#xD;
      the last year, fracture history, history of fracture in mother) were questioned.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was performed on 53 postmenopausal osteoporosis patients who presented to our&#xD;
      osteoporosis outpatient clinic. Following written informed consent, patients were evaluated&#xD;
      for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group&#xD;
      on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle&#xD;
      strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of&#xD;
      walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference&#xD;
      for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale&#xD;
      (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other&#xD;
      clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within&#xD;
      the last year, fracture history, history of fracture in mother) were questioned. SPSS 22.0&#xD;
      program will be used for statistical evaluation and correlation analysis will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sarcopenia in postmenopausal osteoporotic patients</measure>
    <time_frame>6 months</time_frame>
    <description>sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>balance disorder in postmenopausal osteoporotic patients</measure>
    <time_frame>6 months</time_frame>
    <description>balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <condition>Balance; Distorted</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Berg Balance Scale</intervention_name>
    <description>Berg Balance Scale performed for balance disorder</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Timed Up and Go Test</intervention_name>
    <description>Timed Up and Go Test for walking speed</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Jamar hand dynamometer</intervention_name>
    <description>Jamar hand dynamometer for grip strength which correlates with muscle strength of patient</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Calf circumference</intervention_name>
    <description>Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having postmenopausal osteoporosis&#xD;
&#xD;
          -  No other disease that can cause balance disorder&#xD;
&#xD;
          -  Volunteer participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have a disease that will cause balance disorder,&#xD;
&#xD;
          -  Having understanding problem to prevent communication with the patient,&#xD;
&#xD;
          -  The lack of motor function to the balance device.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Postmenopausal osteoporotic patients</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department</name>
      <address>
        <city>Istanbul</city>
        <zip>34732</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bilinç Doğruöz Karatekin</last_name>
      <phone>+905368308709</phone>
      <email>bilincdogruoz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Bilinç Doğruöz Karatekin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Afitap İçağasıoğlu, MD, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yasemin Yumuşakhuylu, MD, Ass. Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fethullah Bayram, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Şeyhmus Yaşin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Bilinç Doğruöz Karatekin</investigator_full_name>
    <investigator_title>MD, Research Assistant of PMR</investigator_title>
  </responsible_party>
  <keyword>osteoporosis</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>balance disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03832088
org study id: MedeniyetOP
nct id: NCT03832088
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study was performed on 53 postmenopausal osteoporosis patients who presented to our
      osteoporosis outpatient clinic. Following written informed consent, patients were evaluated
      for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group
      on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle
      strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of
      walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference
      for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale
      (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other
      clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within
      the last year, fracture history, history of fracture in mother) were questioned.
The study was performed on 53 postmenopausal osteoporosis patients who presented to our
      osteoporosis outpatient clinic. Following written informed consent, patients were evaluated
      for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group
      on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle
      strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of
      walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference
      for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale
      (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other
      clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within
      the last year, fracture history, history of fracture in mother) were questioned. SPSS 22.0
      program will be used for statistical evaluation and correlation analysis will be done.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: sarcopenia in postmenopausal osteoporotic patients
time frame: 6 months
description: sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures
measure: balance disorder in postmenopausal osteoporotic patients
time frame: 6 months
description: balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )
arm group label: postmenopausal osteoporosis
arm group type: Experimental
description: Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders
intervention type: Diagnostic Test
intervention name: Berg Balance Scale
description: Berg Balance Scale performed for balance disorder
arm group label: postmenopausal osteoporosis
intervention type: Diagnostic Test
intervention name: Timed Up and Go Test
description: Timed Up and Go Test for walking speed
arm group label: postmenopausal osteoporosis
intervention type: Diagnostic Test
intervention name: Jamar hand dynamometer
description: Jamar hand dynamometer for grip strength which correlates with muscle strength of patient
arm group label: postmenopausal osteoporosis
intervention type: Diagnostic Test
intervention name: Calf circumference
description: Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.
arm group label: postmenopausal osteoporosis
criteria: 
gender: Female
gender based: Yes
gender description: Postmenopausal osteoporotic patients
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Bilinç Doğruöz Karatekin
investigator title: MD, Research Assistant of PMR
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Sarcopenia
sharing ipd: Undecided