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Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet (SARKOPENIA)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Nandrolone Decanoate
Physiotherapy Intervention
Nutritional Intervention
Placebo
Sponsored by
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: individuals aged 60 years or older through 99 years of age. Patients meeting the following criteria diagnosed with sarcopenia based on EWGSOP 2 criteria from 2019: weakness of muscle strength measured by hand dynamometer ( < 27 kg for men and 16 kg for women) and reduction in densitometry: upper and lower limb muscle mass (ASMM)(below 7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the arms and legs in men less than 20 kg and less than 15 kg in women). Exclusion Criteria: Mini-Mental State Examination (MMSE) score less than 24; malignant neoplasm, lymphoproliferative or myeloproliferative disorders requiring oncologic or palliative treatment and the period before: 5 years in the case of: malignant melanoma, leukemia, Hodgkin's disease, malignant lymphomas, kidney tumors, 12 months in the case of other malignant neoplasms after the completion of surgery, chemotherapy or radiotherapy; history of oncologic diagnosis of focal lesions in the prostate gland; acute and chronic inflammatory diseases of the gastrointestinal tract that present with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.); uncompensated hyper- or hypothyroidism; recent history of myocardial infarction or stroke (up to 4 weeks prior to study entry); history of thromboembolism (up to 6 months prior to study entry) or recurrent thromboembolism; poorly controlled hypertension; liver impairment (AST and/or ALT > 3x normal: AST> 111 U/l and ALT> 123 U/l); 9 Acute kidney injury and/or chronic kidney disease (stage G4 and G5); 10. nephrotic syndrome, acute or chronic glomerulonephritis; 11. advanced circulatory failure (NYHA stages III and IV); 12. Acute and chronic respiratory failure requiring oxygen therapy; 13. Amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, dystrophies, spinal muscular atrophy type IV, primary muscular disorders (ICD-10 G71), toxic-field myopathies, myopathies in the course of infectious and parasitic diseases. Epilepsy; 14. need for treatment during the study period: systemic corticosteroids for more than 3 weeks at a dose equivalent to greater than or equal to 5 mg prednisone; hormone replacement therapy, 5-alpha reductase inhibitors, aromatase inhibitors, anti-estrogenic hormonal drugs with anabolic effects other than nandrolone decanoate, megestrol. 15. Lack of informed consent for participation in the study.

Sites / Locations

  • Centrum Wsparcia Badań KlinicznychRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nandrolone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in physical fitness as assessed by the SPPB test score
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
Change in the 400-meter walk test score
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

Secondary Outcome Measures

lower limb muscle strength
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
Respiratory muscle strength
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
muscle mass
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
muscle mass of the upper and lower limbs
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
score of the Sarc-QoL quality of life questionnaire (validated Polish version)
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

Full Information

First Posted
July 28, 2023
Last Updated
July 28, 2023
Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05978206
Brief Title
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
Acronym
SARKOPENIA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Anticipated)
Primary Completion Date
June 12, 2026 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nandrolone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nandrolone Decanoate
Intervention Description
Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy Intervention
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Intervention
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in physical fitness as assessed by the SPPB test score
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
Time Frame
in the 12th week of the study
Title
Change in the 400-meter walk test score
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
Time Frame
in the 12th week of the study
Secondary Outcome Measure Information:
Title
lower limb muscle strength
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
Time Frame
in the 6th and 12th week of the study
Title
Respiratory muscle strength
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
Time Frame
in the 6th and 12th week of the study
Title
muscle mass
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
Time Frame
in the 6th and 12th week of the study
Title
muscle mass of the upper and lower limbs
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
Time Frame
in the 6th and 12th week of the study
Title
score of the Sarc-QoL quality of life questionnaire (validated Polish version)
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
Time Frame
in the 6th and 12th week of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals aged 60 years or older through 99 years of age. Patients meeting the following criteria diagnosed with sarcopenia based on EWGSOP 2 criteria from 2019: weakness of muscle strength measured by hand dynamometer ( < 27 kg for men and 16 kg for women) and reduction in densitometry: upper and lower limb muscle mass (ASMM)(below 7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the arms and legs in men less than 20 kg and less than 15 kg in women). Exclusion Criteria: Mini-Mental State Examination (MMSE) score less than 24; malignant neoplasm, lymphoproliferative or myeloproliferative disorders requiring oncologic or palliative treatment and the period before: 5 years in the case of: malignant melanoma, leukemia, Hodgkin's disease, malignant lymphomas, kidney tumors, 12 months in the case of other malignant neoplasms after the completion of surgery, chemotherapy or radiotherapy; history of oncologic diagnosis of focal lesions in the prostate gland; acute and chronic inflammatory diseases of the gastrointestinal tract that present with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.); uncompensated hyper- or hypothyroidism; recent history of myocardial infarction or stroke (up to 4 weeks prior to study entry); history of thromboembolism (up to 6 months prior to study entry) or recurrent thromboembolism; poorly controlled hypertension; liver impairment (AST and/or ALT > 3x normal: AST> 111 U/l and ALT> 123 U/l); 9 Acute kidney injury and/or chronic kidney disease (stage G4 and G5); 10. nephrotic syndrome, acute or chronic glomerulonephritis; 11. advanced circulatory failure (NYHA stages III and IV); 12. Acute and chronic respiratory failure requiring oxygen therapy; 13. Amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, dystrophies, spinal muscular atrophy type IV, primary muscular disorders (ICD-10 G71), toxic-field myopathies, myopathies in the course of infectious and parasitic diseases. Epilepsy; 14. need for treatment during the study period: systemic corticosteroids for more than 3 weeks at a dose equivalent to greater than or equal to 5 mg prednisone; hormone replacement therapy, 5-alpha reductase inhibitors, aromatase inhibitors, anti-estrogenic hormonal drugs with anabolic effects other than nandrolone decanoate, megestrol. 15. Lack of informed consent for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iwona Jannasz
Phone
226709188
Ext
+48
Email
iwona.jannasz@spartanska.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Targowski, Prof. PhD, MD
Organizational Affiliation
National Institute of Geriatrics, Rheumatology and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Wsparcia Badań Klinicznych
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Kurek
Phone
603 315 033
Ext
+48
Email
marta.kurek@spartanska.pl

12. IPD Sharing Statement

Learn more about this trial

Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet

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