<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/NCT03806517</url>
  </required_header>
  <id_info>
    <org_study_id>Ordu University 1</org_study_id>
    <nct_id>NCT03806517</nct_id>
  </id_info>
  <brief_title>Bone Mineral Density Changes Among Clinical Subtypes of Parkinson's Disease</brief_title>
  <official_title>Bone Mineral Density in Tremor Dominant Type Compared to Postural Instability Gait Difficulty Type Parkinson's Disease: a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</source>
  <oversight_info>
    <has_dmc>No</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 bone loss in Parkinson's disease (PD) emerges as a non-motor symptom with motor and&#xD;
      non-motor outcomes, such as fracture and musculoskeletal pain. Bone mineral density (BMD) is&#xD;
      decreasing in patients with PD when compared to sex and age-matched healthy controls. The&#xD;
      changes in BMD according to clinical subtypes of PD is unknown. The investigators are&#xD;
      planning to compare the BMD status between the tremor dominant and postural instability and&#xD;
      gait difficulty type of PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are planning to complete this study between January and February 2019. This&#xD;
      study will be performed at Ordu University Education and Research Hospital, Neurology&#xD;
      Department.&#xD;
&#xD;
      All patients admitted to the outpatient clinic will be evaluated in terms of inclusion&#xD;
      criteria. The control group consisted of people who do not have any orthopedic, neurological&#xD;
      or metabolic disorders which may affect the BMD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 10, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 25, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dual-energy X-ray absorptiometry (DEXA)</measure>
    <time_frame>10-15 minutes</time_frame>
    <description>Bone mineral density will be dertermined using DEXA results. The results will be interpreted by WHO (World Health Organization) criteria.&#xD;
: T-score (T-score) is determined by DEXA method. A T-score value of more than minus means that there is excess bone loss.&#xD;
Obsolete osteoporosis: A T-score of less than -2.5 SD and a history of fracture in a patient.&#xD;
Osteoporosis: T-score below -2.5 SD. (Like -3, -4 ...)&#xD;
Osteopenia: T-score between -1 and -2.5 SD&#xD;
Normal: T-score value better than -1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hoehn and Yahr Scale</measure>
    <time_frame>2 minutes</time_frame>
    <description>Disease progression will be assessed with Hoehn and Yahr Scale. The original scale included stages 1 through 5.&#xD;
Stage 0: No signs of disease.&#xD;
Stage 1: Unilateral symptoms only.&#xD;
Stage 2: Bilateral symptoms. No impairment of balance.&#xD;
Stage 3: Balance impairment. Mild to moderate disease. Physically independent.&#xD;
Stage 4: Severe disability, but still able to walk or stand unassisted.&#xD;
Stage 5: Needing a wheelchair or bedridden unless assisted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The UPDRS- ADL section evaluates the impact of Parkinson disease on ADL according to patient's perspective. The ADL section consists of 13 items for gathering information on the patient's own perception of functional impairment due to PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-52. High scores indicate severe impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section</measure>
    <time_frame>10 minutes</time_frame>
    <description>Motor section of UPDRS determines the impairment due to the Parkinson's disease. Rigidity, bradykinesia and tremor items which are relating with upper extremity function will be assessed. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section</measure>
    <time_frame>5 minutes</time_frame>
    <description>Non-motor section of UPDRS evaluates the impact of the non motor symptoms in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complications section of UPDRS evaluates the complications after the levodopa treatment in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-24.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Bone Loss</condition>
  <arm_group>
    <arm_group_label>Tremor dominant type group</arm_group_label>
    <description>Tremor dominant type (TDT) group will consist of the patients with tremor premotor symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIGD dominant type group</arm_group_label>
    <description>Postural instability and gait difficulty dominant type (PIGDT) group will consist of the patients with axial premotor symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <description>Healthy control group will consist of the subjects with same age and sex matched individuals in PD group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The PD group will be selcted from Neurology Department, Movement Disorders Clinic.&#xD;
&#xD;
        The control group will be selected from community population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For TDT and PIGDT PD group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Having additional orthopedic and neurological disorders Having metabolic disease, Having&#xD;
        steroid drug use&#xD;
&#xD;
        For Control group&#xD;
&#xD;
        The similar age and sex-matched healthy individuals who have no orthopedic, metabolic and&#xD;
        neurological disorders, and steroid use will be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevim ACARÖZ CANDAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>T.C. ORDU ÜNİVERSİTESİ</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sevim ACARÖZ CANDAN, PhD</last_name>
    <phone>00905071027447</phone>
    <email>fzt_acaroz@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sevim ACARÖZ CANDAN</name>
      <address>
        <city>Ordu</city>
        <state>Altinordu</state>
        <zip>52100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Sevim ACARÖZ CANDAN</investigator_full_name>
    <investigator_title>Head of Department of Physiotherapy and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>bone mineral density</keyword>
  <keyword>Parkinson's disease</keyword>
  <keyword>tremor</keyword>
  <keyword>postural instability and gait difficulty</keyword>
  <keyword>akinetic-rigid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03806517
org study id: Ordu University 1
nct id: NCT03806517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The bone loss in Parkinson's disease (PD) emerges as a non-motor symptom with motor and
      non-motor outcomes, such as fracture and musculoskeletal pain. Bone mineral density (BMD) is
      decreasing in patients with PD when compared to sex and age-matched healthy controls. The
      changes in BMD according to clinical subtypes of PD is unknown. The investigators are
      planning to compare the BMD status between the tremor dominant and postural instability and
      gait difficulty type of PD.
The investigators are planning to complete this study between January and February 2019. This
      study will be performed at Ordu University Education and Research Hospital, Neurology
      Department.

      All patients admitted to the outpatient clinic will be evaluated in terms of inclusion
      criteria. The control group consisted of people who do not have any orthopedic, neurological
      or metabolic disorders which may affect the BMD.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: Dual-energy X-ray absorptiometry (DEXA)
time frame: 10-15 minutes
description: Bone mineral density will be dertermined using DEXA results. The results will be interpreted by WHO (World Health Organization) criteria.
: T-score (T-score) is determined by DEXA method. A T-score value of more than minus means that there is excess bone loss.
Obsolete osteoporosis: A T-score of less than -2.5 SD and a history of fracture in a patient.
Osteoporosis: T-score below -2.5 SD. (Like -3, -4 ...)
Osteopenia: T-score between -1 and -2.5 SD
Normal: T-score value better than -1
measure: Hoehn and Yahr Scale
time frame: 2 minutes
description: Disease progression will be assessed with Hoehn and Yahr Scale. The original scale included stages 1 through 5.
Stage 0: No signs of disease.
Stage 1: Unilateral symptoms only.
Stage 2: Bilateral symptoms. No impairment of balance.
Stage 3: Balance impairment. Mild to moderate disease. Physically independent.
Stage 4: Severe disability, but still able to walk or stand unassisted.
Stage 5: Needing a wheelchair or bedridden unless assisted.
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
time frame: 10 minutes
description: The UPDRS- ADL section evaluates the impact of Parkinson disease on ADL according to patient's perspective. The ADL section consists of 13 items for gathering information on the patient's own perception of functional impairment due to PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-52. High scores indicate severe impairment.
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
time frame: 10 minutes
description: Motor section of UPDRS determines the impairment due to the Parkinson's disease. Rigidity, bradykinesia and tremor items which are relating with upper extremity function will be assessed. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-56.
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section
time frame: 5 minutes
description: Non-motor section of UPDRS evaluates the impact of the non motor symptoms in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-52.
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section
time frame: 5 minutes
description: Complications section of UPDRS evaluates the complications after the levodopa treatment in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-24.
arm group label: Tremor dominant type group
description: Tremor dominant type (TDT) group will consist of the patients with tremor premotor symptoms.
arm group label: PIGD dominant type group
description: Postural instability and gait difficulty dominant type (PIGDT) group will consist of the patients with axial premotor symptoms.
arm group label: Healthy control group
description: Healthy control group will consist of the subjects with same age and sex matched individuals in PD group.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sevim ACARÖZ CANDAN
role: Principal Investigator
affiliation: T.C. ORDU ÜNİVERSİTESİ
last name: Sevim ACARÖZ CANDAN, PhD
phone: 00905071027447
email: fzt_acaroz@hotmail.com
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Sevim ACARÖZ CANDAN
investigator title: Head of Department of Physiotherapy and Rehabilitation
mesh term: Parkinson Disease