xml: <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/NCT05978206</url>
    </required_header>
    <id_info>
      <org_study_id>NIGRIR_002SARKOPENIA</org_study_id>
      <nct_id>NCT05978206</nct_id>
    </id_info>
    <brief_title>Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet</brief_title>
    <acronym>SARKOPENIA</acronym>
    <official_title>Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Nandrolone Decanoate Therapy and Therapy With Complex Physiotherapy and Diet in the Treatment of Sarcopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Agency, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</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>
        This is a single-center, prospective, randomized, double-blind (pharmacotherapy),&#xD;
        placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II&#xD;
        clinical trial to determine the usefulness of nandrolone decanoate in a new indication&#xD;
        (sarcopenia).&#xD;
  &#xD;
        Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular&#xD;
        injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg&#xD;
        intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive&#xD;
        comprehensive physiotherapy and nutritional intervention.&#xD;
  &#xD;
        There will be 5 outpatient visits to the research center. The procedures and assessments&#xD;
        performed as part of the study are listed in the study schedule.&#xD;
  &#xD;
        It is planned to include 168 patients in the study, which, assuming a 10% level of&#xD;
        non-completion of the program, will result in the examination of 152 patients (76 in each&#xD;
        arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle&#xD;
        weakness measured with a hand dynamometer (&lt; 27 kg for men and 16 kg for women) and with a&#xD;
        decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5&#xD;
        kg/m2 in women) or total muscle mass of the upper and lower extremities (&lt; 20 kg in men and &lt;&#xD;
        15 kg in women) by densitometry.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 12, 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in physical fitness as assessed by the SPPB test score</measure>
      <time_frame>in the 12th week of the study</time_frame>
      <description>Change in physical fitness as assessed by the SPPB test score (4- meter gait speed test version) in points, at the 5th study visit relative to the test score performed at visit 1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the 400-meter walk test score</measure>
      <time_frame>in the 12th week of the study</time_frame>
      <description>Change in the 400-meter walk test score in time units, at the 5th test visit, relative to the test score taken at visit 1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lower limb muscle strength</measure>
      <time_frame>in the 6th and 12th week of the study</time_frame>
      <description>lower limb muscle strength assessed with the result of the test of getting up 5 times from a chair per unit of time, upper limb muscle strength assessed with the result of the dynamometric handgrip test in kilograms during the 3rd and 5th visit of the examination in relation to the result made during the 1st visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory muscle strength</measure>
      <time_frame>in the 6th and 12th week of the study</time_frame>
      <description>Respiratory muscle strength assessed as a result of changes in airway pressures during inhalation and exhalation during the 5th visit of the study in relation to the result of the test performed at visit 1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>muscle mass</measure>
      <time_frame>in the 6th and 12th week of the study</time_frame>
      <description>muscle mass: assessed on the basis of the content of lean body mass of the upper and lower limbs in the study of body composition analysis using the electrical bioimpedance method; during the 3rd and 5th study visit in relation to the result of the study performed during visit 1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>muscle mass of the upper and lower limbs</measure>
      <time_frame>in the 6th and 12th week of the study</time_frame>
      <description>muscle mass of the upper and lower limbs: assessed on the basis of the content of lean body mass of the upper and lower limbs in the densitometry test during the 5th visit of the study in relation to the result of the test performed during visit 1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>score of the Sarc-QoL quality of life questionnaire (validated Polish version)</measure>
      <time_frame>in the 6th and 12th week of the study</time_frame>
      <description>score of the Sarc-QoL quality of life questionnaire (validated Polish version) during the 5th visit of the study in relation to the result of the study performed during visit 1</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">168</enrollment>
    <condition>Sarcopenia</condition>
    <arm_group>
      <arm_group_label>Nandrolone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nandrolone Decanoate</intervention_name>
      <description>Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo</description>
      <arm_group_label>Nandrolone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physiotherapy Intervention</intervention_name>
      <description>The physiotherapeutic intervention includes the following components:&#xD;
  Strength training will include strength exercises 3 x a week x 30 min - load from 60% to 80% 1RM for individual muscle groups, - 10 repetitions of the exercise, - 1-3 series in 1 session (break between sessions 60 seconds).&#xD;
  Endurance training will include aerobic exercises (cycle ergometer, treadmill, general fitness exercises) 3 times a week x 30 minutes, load from 60% to 80% of maximum heart rate.</description>
      <arm_group_label>Nandrolone</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nutritional Intervention</intervention_name>
      <description>An individual diet in terms of calorific value and the content of energy substrates - proteins, fats and carbohydrates, as well as other nutrients, in accordance with specific nutrition standards.</description>
      <arm_group_label>Nandrolone</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. individuals aged 60 years or older through 99 years of age.&#xD;
  &#xD;
            2. Patients meeting the following criteria diagnosed with sarcopenia based on EWGSOP 2&#xD;
               criteria from 2019:&#xD;
  &#xD;
                 -  weakness of muscle strength measured by hand dynamometer ( &lt; 27 kg for men and 16&#xD;
                    kg for women) and&#xD;
  &#xD;
                 -  reduction in densitometry:&#xD;
  &#xD;
                      -  upper and lower limb muscle mass (ASMM)(below 7.0 kg/m2 height in men and&#xD;
                         5.5 kg/m2 in women) or&#xD;
  &#xD;
                      -  total muscle mass of the arms and legs in men less than 20 kg and less than&#xD;
                         15 kg in women).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Mini-Mental State Examination (MMSE) score less than 24;&#xD;
  &#xD;
            2. malignant neoplasm, lymphoproliferative or myeloproliferative disorders requiring&#xD;
               oncologic or palliative treatment and the period before: 5 years in the case of:&#xD;
               malignant melanoma, leukemia, Hodgkin's disease, malignant lymphomas, kidney tumors,&#xD;
               12 months in the case of other malignant neoplasms after the completion of surgery,&#xD;
               chemotherapy or radiotherapy;&#xD;
  &#xD;
            3. history of oncologic diagnosis of focal lesions in the prostate gland;&#xD;
  &#xD;
            4. acute and chronic inflammatory diseases of the gastrointestinal tract that present&#xD;
               with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.);&#xD;
  &#xD;
            5. uncompensated hyper- or hypothyroidism;&#xD;
  &#xD;
            6. recent history of myocardial infarction or stroke (up to 4 weeks prior to study&#xD;
               entry); history of thromboembolism (up to 6 months prior to study entry) or recurrent&#xD;
               thromboembolism;&#xD;
  &#xD;
            7. poorly controlled hypertension;&#xD;
  &#xD;
            8. liver impairment (AST and/or ALT &gt; 3x normal: AST&gt; 111 U/l and ALT&gt; 123 U/l); 9 Acute&#xD;
               kidney injury and/or chronic kidney disease (stage G4 and G5);&#xD;
  &#xD;
          10. nephrotic syndrome, acute or chronic glomerulonephritis; 11. advanced circulatory&#xD;
          failure (NYHA stages III and IV); 12. Acute and chronic respiratory failure requiring&#xD;
          oxygen therapy; 13. Amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis,&#xD;
          dystrophies, spinal muscular atrophy type IV, primary muscular disorders (ICD-10 G71),&#xD;
          toxic-field myopathies, myopathies in the course of infectious and parasitic diseases.&#xD;
          Epilepsy; 14. need for treatment during the study period:&#xD;
  &#xD;
            -  systemic corticosteroids for more than 3 weeks at a dose equivalent to greater than or&#xD;
               equal to 5 mg prednisone;&#xD;
  &#xD;
            -  hormone replacement therapy,&#xD;
  &#xD;
            -  5-alpha reductase inhibitors,&#xD;
  &#xD;
            -  aromatase inhibitors,&#xD;
  &#xD;
            -  anti-estrogenic hormonal drugs with anabolic effects other than nandrolone decanoate,&#xD;
  &#xD;
            -  megestrol. 15. Lack of informed consent for participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tomasz Targowski, Prof. PhD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Geriatrics, Rheumatology and Rehabilitation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Iwona Jannasz</last_name>
      <phone>226709188</phone>
      <phone_ext>+48</phone_ext>
      <email>iwona.jannasz@spartanska.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centrum Wsparcia Badań Klinicznych</name>
        <address>
          <city>Warsaw</city>
          <state>Mazowieckie</state>
          <zip>02-637</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marta Kurek</last_name>
        <phone>603 315 033</phone>
        <phone_ext>+48</phone_ext>
        <email>marta.kurek@spartanska.pl</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nandrolone Decanoate</mesh_term>
      <mesh_term>Nandrolone</mesh_term>
      <mesh_term>Nandrolone phenpropionate</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978206
  org study id: NIGRIR_002SARKOPENIA
  nct id: NCT05978206
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, prospective, randomized, double-blind (pharmacotherapy),
        placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II
        clinical trial to determine the usefulness of nandrolone decanoate in a new indication
        (sarcopenia).
  
        Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular
        injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg
        intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive
        comprehensive physiotherapy and nutritional intervention.
  
        There will be 5 outpatient visits to the research center. The procedures and assessments
        performed as part of the study are listed in the study schedule.
  
        It is planned to include 168 patients in the study, which, assuming a 10% level of
        non-completion of the program, will result in the examination of 152 patients (76 in each
        arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle
        weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a
        decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5
        kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and <
        15 kg in women) by densitometry.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change in physical fitness as assessed by the SPPB test score
  time frame: in the 12th week of the study
  description: Change in physical fitness as assessed by the SPPB test score (4- meter gait speed test version) in points, at the 5th study visit relative to the test score performed at visit 1
  measure: Change in the 400-meter walk test score
  time frame: in the 12th week of the study
  description: Change in the 400-meter walk test score in time units, at the 5th test visit, relative to the test score taken at visit 1
  measure: lower limb muscle strength
  time frame: in the 6th and 12th week of the study
  description: lower limb muscle strength assessed with the result of the test of getting up 5 times from a chair per unit of time, upper limb muscle strength assessed with the result of the dynamometric handgrip test in kilograms during the 3rd and 5th visit of the examination in relation to the result made during the 1st visit
  measure: Respiratory muscle strength
  time frame: in the 6th and 12th week of the study
  description: Respiratory muscle strength assessed as a result of changes in airway pressures during inhalation and exhalation during the 5th visit of the study in relation to the result of the test performed at visit 1
  measure: muscle mass
  time frame: in the 6th and 12th week of the study
  description: muscle mass: assessed on the basis of the content of lean body mass of the upper and lower limbs in the study of body composition analysis using the electrical bioimpedance method; during the 3rd and 5th study visit in relation to the result of the study performed during visit 1
  measure: muscle mass of the upper and lower limbs
  time frame: in the 6th and 12th week of the study
  description: muscle mass of the upper and lower limbs: assessed on the basis of the content of lean body mass of the upper and lower limbs in the densitometry test during the 5th visit of the study in relation to the result of the test performed during visit 1
  measure: score of the Sarc-QoL quality of life questionnaire (validated Polish version)
  time frame: in the 6th and 12th week of the study
  description: score of the Sarc-QoL quality of life questionnaire (validated Polish version) during the 5th visit of the study in relation to the result of the study performed during visit 1
  arm group label: Nandrolone
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Nandrolone Decanoate
  description: Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo
  arm group label: Nandrolone
  intervention type: Behavioral
  intervention name: Physiotherapy Intervention
  description: The physiotherapeutic intervention includes the following components:
  Strength training will include strength exercises 3 x a week x 30 min - load from 60% to 80% 1RM for individual muscle groups, - 10 repetitions of the exercise, - 1-3 series in 1 session (break between sessions 60 seconds).
  Endurance training will include aerobic exercises (cycle ergometer, treadmill, general fitness exercises) 3 times a week x 30 minutes, load from 60% to 80% of maximum heart rate.
  arm group label: Nandrolone
  arm group label: Placebo
  intervention type: Behavioral
  intervention name: Nutritional Intervention
  description: An individual diet in terms of calorific value and the content of energy substrates - proteins, fats and carbohydrates, as well as other nutrients, in accordance with specific nutrition standards.
  arm group label: Nandrolone
  arm group label: Placebo
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Tomasz Targowski, Prof. PhD, MD
  role: Principal Investigator
  affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
  last name: Iwona Jannasz
  phone: 226709188
  phone ext: +48
  email: iwona.jannasz@spartanska.pl
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Sarcopenia
  mesh term: Nandrolone Decanoate
  mesh term: Nandrolone
  mesh term: Nandrolone phenpropionate