Actively Recruiting
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2026-04-08
168
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 60 and 99 years
- Diagnosed with sarcopenia based on muscle weakness measured by hand dynamometer (less than 27 kg for men and less than 16 kg for women)
- Reduced muscle mass confirmed by densitometry: ASMM below 7.0 kg/m2 height in men and 5.5 kg/m2 in women, or total muscle mass of arms and legs less than 20 kg in men and less than 15 kg in women
You will not qualify if you...
- Mini-Mental State Examination score below 24
- History of malignant neoplasm, lymphoproliferative or myeloproliferative disorders requiring oncologic or palliative treatment within 5 years for certain cancers or within 12 months for others
- History of focal lesions in the prostate gland
- Acute or chronic inflammatory gastrointestinal diseases causing malabsorption
- Uncompensated thyroid disorders
- Recent myocardial infarction or stroke within 4 weeks, thromboembolism within 6 months, or recurrent thromboembolism
- Poorly controlled hypertension
- Liver impairment with AST or ALT more than 3 times the normal
- Acute kidney injury or chronic kidney disease stage G4 or G5
- Nephrotic syndrome or glomerulonephritis
- Advanced heart failure (NYHA stages III or IV)
- Respiratory failure requiring oxygen therapy
- Neuromuscular diseases including amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, dystrophies, spinal muscular atrophy type IV, primary muscular disorders, toxic-field myopathies, infectious or parasitic myopathies, epilepsy
- Need for treatment during the study with systemic corticosteroids over 3 weeks at doses equal or above 5 mg prednisone, hormone replacement therapy, 5-alpha reductase inhibitors, aromatase inhibitors, anti-estrogenic hormonal drugs with anabolic effects other than nandrolone decanoate, or megestrol
- Lack of informed consent for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
I
Iwona Jannasz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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