Can a steroid help seniors regain muscle? new trial investigates
NCT ID NCT05978206
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called nandrolone decanoate, combined with a structured exercise and diet program, can improve strength and mobility in older adults with sarcopenia (age-related muscle loss). About 168 people aged 60–99 will receive either the drug or a placebo, plus the same exercise and diet plan, for 12 weeks. Researchers will measure changes in walking speed, chair-stand time, and overall physical function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nandrolone decanoate (an anabolic steroid)
- What this could lead to
- If it works, this could point toward a treatment for sarcopenia that combines medication, exercise, and diet to help older adults regain strength and mobility.
- What could go wrong
- This is an early Phase 2 trial with only 168 people, so results may not apply to everyone. The steroid may cause side effects like hormonal changes or liver issues, and the benefit over exercise and diet alone is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centrum Wsparcia Badań Klinicznych
RECRUITINGWarsaw, Masovian Voivodeship, 02-637, Poland
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