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

NCT ID: NCT05978206

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2026-10-30

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nandrolone

Group Type: EXPERIMENTAL

Nandrolone Decanoate

Intervention Type: DRUG

Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo

Physiotherapy Intervention

Intervention Type: BEHAVIORAL

The physiotherapeutic intervention includes the following components:

1. 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).

2. 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.

Nutritional Intervention

Intervention Type: BEHAVIORAL

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Physiotherapy Intervention

Intervention Type: BEHAVIORAL

The physiotherapeutic intervention includes the following components:

1. 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).

2. 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.

Nutritional Intervention

Intervention Type: BEHAVIORAL

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.

Placebo

Intervention Type: DRUG

Placebo

Interventions

Nandrolone Decanoate

Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo

Intervention Type: DRUG

Physiotherapy Intervention

The physiotherapeutic intervention includes the following components:

1. 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).

2. 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

Nutritional Intervention

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: BEHAVIORAL

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. individuals aged 60 years or older through 99 years of age.

2. 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

1. Mini-Mental State Examination (MMSE) score less than 24;

2. 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;

3. history of oncologic diagnosis of focal lesions in the prostate gland;

4. acute and chronic inflammatory diseases of the gastrointestinal tract that present with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.);

5. uncompensated hyper- or hypothyroidism;

6. 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;

7. poorly controlled hypertension;

8. 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Agency, Poland

OTHER_GOV

Sponsor Role: collaborator

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Targowski, Prof. PhD, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Geriatrics, Rheumatology and Rehabilitation

Locations

Centrum Wsparcia Badań Klinicznych

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Iwona Jannasz

Role: CONTACT

iwona.jannasz@spartanska.pl

226709188 ext. +48

Facility Contacts

Marta Kurek

Role: primary

marta.kurek@spartanska.pl

603 315 033 ext. +48

Other Identifiers

NIGRIR_002SARKOPENIA

Identifier Type: -

Identifier Source: org_study_id