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Tests treatment safety and results for Sarcopenia
Official title Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
ClinicalTrials.gov ID: NCT05978206
What this study is testing
What is Nandrolone Decanoate?
Nandrolone Decanoate is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for sarcopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 99
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.