<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/NCT02977949</url>
  </required_header>
  <id_info>
    <org_study_id>TH 05-2</org_study_id>
    <nct_id>NCT02977949</nct_id>
  </id_info>
  <brief_title>The Effects of Seasonal Changes in Osteoporosis Treatment</brief_title>
  <official_title>The Effects of Seasonal Changes in Osteoporosis Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toshihiko Kono</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomidahama Hospital</source>
  <brief_summary>
    <textblock>
      There are few reports concerning to the seasonal variation of osteoporosis treatment. In this&#xD;
      study, we plan to compare clinical efficacy and safety by seasons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated&#xD;
      with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is&#xD;
      considered to be the best estimate of body stores of vitamin D and the seasonal variation of&#xD;
      25OHD is well known. But there are few reports concerning to the seasonal variation of&#xD;
      osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by&#xD;
      seasons in patients treated by raloxifene.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.</measure>
    <time_frame>Up to 36 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Selective Estrogen Receptor Modulator (SERM)</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raloxifene</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Osteoporosis patients using raloxifene more for two years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who could not use SERM&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rui Niimi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Tomidahama Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rui Niimi, MD</last_name>
    <phone>(81)-59-365-0023</phone>
    <email>furikakefuri@hotmail.co.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tomidahama Hospital</name>
      <address>
        <city>Yokkaichi</city>
        <state>Mie</state>
        <zip>510-8008</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Niimi, MD, PhD</last_name>
      <phone>(81)-59-365-0023</phone>
      <email>furikakefuri@hotmail.co.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 26, 2016</last_update_submitted>
  <last_update_submitted_qc>November 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tomidahama Hospital</investigator_affiliation>
    <investigator_full_name>Toshihiko Kono</investigator_full_name>
    <investigator_title>Head of Hospital</investigator_title>
  </responsible_party>
  <keyword>SERM</keyword>
  <keyword>Season</keyword>
  <keyword>Variation</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raloxifene Hydrochloride</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/NCT02977949
org study id: TH 05-2
nct id: NCT02977949
lead sponsor: 
There are few reports concerning to the seasonal variation of osteoporosis treatment. In this
      study, we plan to compare clinical efficacy and safety by seasons.
Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated
      with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is
      considered to be the best estimate of body stores of vitamin D and the seasonal variation of
      25OHD is well known. But there are few reports concerning to the seasonal variation of
      osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by
      seasons in patients treated by raloxifene.
observational model: Case-Only
time perspective: Prospective
measure: Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.
time frame: Up to 36 months
intervention type: Drug
intervention name: Raloxifene
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rui Niimi, MD
role: Study Director
affiliation: Tomidahama Hospital
last name: Rui Niimi, MD
phone: (81)-59-365-0023
email: furikakefuri@hotmail.co.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor-Investigator
investigator affiliation: Tomidahama Hospital
investigator full name: Toshihiko Kono
investigator title: Head of Hospital
mesh term: Osteoporosis
mesh term: Raloxifene Hydrochloride