<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/NCT01694355</url>
  </required_header>
  <id_info>
    <org_study_id>sor0089-12-ctil</org_study_id>
    <secondary_id>SCRC12008</secondary_id>
    <nct_id>NCT01694355</nct_id>
  </id_info>
  <brief_title>The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women</brief_title>
  <acronym>Vitamin D</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis&#xD;
      is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and&#xD;
      will cause low BMD estimation in DXA scan due to insufficient bone mineralization.&#xD;
&#xD;
      We assume that among these postmenopausal women, Vitamin D treatment will improve bone&#xD;
      mineralization and will cause a rapid increase in BMD. According to the results,&#xD;
      bisphosphonates therapy may be an unnecessary treatment.&#xD;
&#xD;
      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its&#xD;
      correction on Bone Mineral Density (BMD) in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMD (Z score) following 10 months of vitamin D supplementation</measure>
    <time_frame>10-14 months</time_frame>
    <description>Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.</measure>
    <time_frame>10-14 months</time_frame>
    <description>Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <arm_group_label>Vitamin D treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Informed Consent.&#xD;
&#xD;
          2. Female age 55-70&#xD;
&#xD;
          3. At least 2 years past menopause&#xD;
&#xD;
          4. 25(OH)D≤ 17.5nmol/L (≤7 ng/ml)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Vitamin D levels &gt; 30nmol/L in the past 2 years 2. Creatinine &gt; 1.2%mg 3. Calcium ≥&#xD;
        10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D&#xD;
        treatment over 2 months in the past 2 years 6. BMI&gt;35 or BMI&lt;20 7. Menopause before age 45&#xD;
        8. Type 1 diabetes 9. Concomitant disease:&#xD;
&#xD;
          1. Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac&#xD;
             disease)&#xD;
&#xD;
          2. Rheumatoid arthritis&#xD;
&#xD;
          3. Nephrotic syndrome&#xD;
&#xD;
          4. Chronic renal failure&#xD;
&#xD;
          5. Primary hyperparathyroidism&#xD;
&#xD;
          6. Hyperthyroidism&#xD;
&#xD;
          7. Malignancies excluding skin cancers (within the last 5 years)&#xD;
&#xD;
          8. Kidney stones or history of renal colic 10. Medications:&#xD;
&#xD;
          9. Steroids use (past or present)&#xD;
&#xD;
         10. Anti rejection drugs in the last 5 years&#xD;
&#xD;
         11. Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years&#xD;
&#xD;
         12. Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista,&#xD;
             Protelos, (past or present)&#xD;
&#xD;
         13. Post menopausal HRT (in the last 10 years)&#xD;
&#xD;
         14. Aromatase inhibitors: Femara, Arimadex (past or present)&#xD;
&#xD;
         15. Current use of PPIs (lanton, controloc, zoton, omepradex etc)&#xD;
&#xD;
         16. Current or past use of anti depressant SSRI (favoxil,cipralex etc)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Be'er Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soroka University Medical Center</investigator_affiliation>
    <investigator_full_name>Merav Fraenkel</investigator_full_name>
    <investigator_title>Senior Endocrinologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01694355
org study id: sor0089-12-ctil
secondary id: SCRC12008
nct id: NCT01694355
lead sponsor: 
has dmc: No
It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis
      is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and
      will cause low BMD estimation in DXA scan due to insufficient bone mineralization.

      We assume that among these postmenopausal women, Vitamin D treatment will improve bone
      mineralization and will cause a rapid increase in BMD. According to the results,
      bisphosphonates therapy may be an unnecessary treatment.

      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its
      correction on Bone Mineral Density (BMD) in postmenopausal women.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in BMD (Z score) following 10 months of vitamin D supplementation
time frame: 10-14 months
description: Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
measure: To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.
time frame: 10-14 months
description: Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
arm group label: Vitamin D treatment
arm group type: Experimental
description: We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.
intervention type: Drug
intervention name: Vitamin D
arm group label: Vitamin D treatment
criteria: 
gender: Female
minimum age: 55 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Soroka University Medical Center
investigator full name: Merav Fraenkel
investigator title: Senior Endocrinologist
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
sharing ipd: No