Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet (SARKOPENIA)
Sarcopenia
About this trial
This is an interventional treatment trial for Sarcopenia
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.
Sites / Locations
- Centrum Wsparcia Badań KlinicznychRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Nandrolone
Placebo