Effect of nandrolone and therapy on sarcopenia in older adults

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

This study is testing if a combination of nandrolone and therapy can help older adults with sarcopenia gain muscle strength and mass.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 60 Years to 99 Years
• Sex: All
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (network)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Warsaw, Masovian Voivodeship)
• Trial ID: NCT05978206 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of nandrolone decanoate combined with comprehensive physiotherapy and nutritional intervention in treating sarcopenia in individuals aged 60 to 99. Participants will be randomly assigned to receive either nandrolone or a placebo over a 12-week period, with assessments conducted during five outpatient visits. The study aims to evaluate improvements in muscle strength and mass among older adults diagnosed with sarcopenia based on established criteria.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 years or older diagnosed with sarcopenia according to specific clinical criteria.

Not a fit: Patients with cognitive impairments or certain malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve muscle strength and overall physical function in older adults suffering from sarcopenia.

How similar studies have performed: While the use of nandrolone for sarcopenia is novel, similar interventions combining pharmacotherapy with physiotherapy have shown promise in other studies.

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.

Where this trial is running

Warsaw, Masovian Voivodeship

• Centrum Wsparcia Badań Klinicznych — Warsaw, Masovian Voivodeship, Poland (RECRUITING)

Study contacts

• Principal investigator: Tomasz Targowski, Prof. PhD, MD — National Institute of Geriatrics, Rheumatology and Rehabilitation
• Study coordinator: Iwona Jannasz

Conditions: Sarcopenia