<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201212206975N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Alendronate for the prevention of osteoporosis in ankylosing spondylitis</public_title>
      <acronym></acronym>
      <scientific_title>A randomized, double-blind, placebo-controlled pilot study of the efficacy of alendronate on the prevention of bone loss in patients with early ankylosing spondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7434</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: For elimination of the possibility of any probable bias due to the knowledge of patients and assessing physicians about the type of treatment we will perform a double blind study. Alendronate and placebo will be encapsulated and for this reason patients and assessing physicians do not have any knowledge about the type of treatment. Randomization will be performed by the Randlist software and every patient will be entered in the treatment or placebo groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ankylosing spondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group will receive placebo for 12 months. Intervention 2: Treatment group will receive alendronate sodium 70 mg tablet (Ostomod, Modava company) with 70mg/week (one tablet at week)dose orally for 12 months.  Alendronate is a bisphosphonate which binds to the hydroxyapatite in bone and act as a inhibitor of the resorption of bone. Chemically, it is described as bisphosphonic acid monosodium salt trihydrate. It should be taken alone on an empty stomach first thing in the morning with at least 240 mL of water. After administration, the patient should not have food, drink, medications, or supplements for at least one-half hour.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrzad Hajiallilo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rheumatology Research Team, 4th floor, Emam Reza Hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167747899</zip>
        <telephone>+98 41 1337 3966</telephone>
        <email>hajialilo@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khabbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rheumatology Research Team, 4th floor, Emam Reza Hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167747899</zip>
        <telephone>+98 41 1337 3966</telephone>
        <email>khabbazia@tbzmed.ac.ir; dr_khabbazi@yahoo.com</email>
        <affiliation>Rheumatology Research Team, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Schober index≥5; Normal hip joint in the pelvic radiography; Absence or rarity of syndesmophyte in the spine radiography (Taylor index≤1);  Normal bone density or mild osteopenia (T-score≥-1.5)&#13;
Exclusion criteria: &#13;
Use of drugs which increase bone density like bisphosphonates; Use of steroids and biological agents; Coexistence of other disease which decreases bone density: including hyperparathyroidism, diabetes, hyper and hypothyroidism, osteomalasia, liver failure, renal failure</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ankylosing spondylitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group will receive placebo for 12 months.</i_keyword>
      <i_keyword>Treatment group will receive alendronate sodium 70 mg tablet (Ostomod, Modava company) with 70mg/week (one tablet at week)dose orally for 12 months.  Alendronate is a bisphosphonate which binds to the hydroxyapatite in bone and act as a inhibitor of the resorption of bone. Chemically, it is described as bisphosphonic acid monosodium salt trihydrate. It should be taken alone on an empty stomach first thing in the morning with at least 240 mL of water. After administration, the patient should not have food, drink, medications, or supplements for at least one-half hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bone density. Timepoint: 12 months after intervention (at the end of study). Method of measurement: Bone mineral density measurement as gram/cm² by the DEXA method with Hologic QRD model instrument from lumbar and pelvic area.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Osteoporotic fracture. Timepoint: Every 3 months until 12 months. Method of measurement: History, physical examination, and radiography.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-27</approval_date>
        <contact_name>Ethic committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Ethic committee, Vice chancellor for research, 4th floor, Faculty of medicine, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
