Effect of nandrolone and therapy on sarcopenia in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: iwona.jannasz@spartanska.pl
• Phone: 226709188

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Lower-limb rehabilitation robot training with nutrition education for sarcopenia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.