Status:
RECRUITING
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
Lead Sponsor:
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Sarcopenia
Eligibility:
All Genders
60-99 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05978206
Start Date
August 10 2023
End Date
October 30 2026
Last Update
November 14 2023
Active Locations (1)
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1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637