Evaluation of Nandrolone Decanoate, Physiotherapy, and Diet in Sarcopenia Treatment: A Randomized, Double-Blind, Placebo-Controlled Trial
- Trial ID
- 2024-517178-48-00
- Protocol
- NIGRIR_002SARKOPENIA
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the clinical efficacy of nandrolone decanoate pharmacotherapy in the treatment of sarcopenia. This evaluation is clinically significant due to the progressive loss of muscle mass and function associated with this condition, which increases the risk of functional impairment, falls, and mortality in older populations. The secondary objectives include:
- Analysis of an inflammatory factors panel via ELISA tests to identify potential biomarkers of the disease.
- Assessment of the microbiome and metabolome to determine the effectiveness of the combined pharmacotherapy, diet, and physiotherapy.
- Identification of metabolic biomarkers through metabolome analysis.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients diagnosed with sarcopenia. Participants must be between 60 and 99 years of age. Eligibility is determined by the EWGSOP 2 criteria, requiring evidence of muscle strength weakness through hand dynamometry or an abnormal chair rise test. Furthermore, diagnosis requires a reduction in muscle mass or skeletal muscle mass as assessed via densitometry or bioelectrical impedance analysis.
Plans and Procedures
This Phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of nandrolone decanoate therapy combined with complex physiotherapy and diet in the treatment of sarcopenia. The research methodology involves the administration of either the test substance or a placebo via intramuscular injection. The study procedure includes a screening visit to assess eligibility based on age and specific muscle mass and strength criteria, followed by subsequent study visits. The primary endpoints involve assessing changes in physical fitness through the Short Physical Performance Battery (SPPB) and the 400-meter walk test at the fifth study visit relative to the baseline assessment. The overall duration of the study is expected to extend through April 2028.
Treatment
The experimental treatment consists of nandrolone decanoate, provided as a solution for injection. The administered dose is 50 mg/ml via an intramuscular route. This substance is being evaluated for the treatment of sarcopenia.
The control group receives a placebo consisting of sodium chloride in a solution for injection. This administration is performed via an intramuscular route at a volume of 1 ml.
Efficacy
The efficacy of nandrolone decanoate in the treatment of sarcopenia is evaluated through specific primary endpoints. The assessment focuses on the change in physical fitness, which is measured using the Short Physical Performance Battery (SPPB) test score, specifically the 4-meter gait speed test version. This change is calculated by comparing the score obtained at the 5th study visit to the baseline score recorded at visit 1.
Additionally, efficacy is assessed by measuring the change in the 400-meter walk test score. This parameter is quantified in time units and is evaluated at the 5th study visit relative to the initial measurement performed at visit 1.
Inclusion and Exclusion Criteria
Inclusion 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) or abnormal result of the chair rise test (i.e. changing from sitting to standing position on a chair 5 times in > 15 seconds) and • reduction in densitometry: men and 5.5 kg/m2 in women) or o total muscle mass of the arms and legs in men less than 20 kg and less than 15 kg in women) or a decrease below the norm (for age, gender, height and total body mass) of whole body skeletal muscle mass (SMM) in a bioelectrical impedance (BIA) examination using the Maltron BioScan touch i8 device, medical certificate CE 2797.
Exclusion Criteria
- Mini-Mental State Examination (MMSE) score less than 19;
- Malignant tumor, lymphoproliferative or myeloproliferative diseases requiring oncological or palliative treatment and the period before expiry: 5 years in the case of: prostate cancer, malignant melanoma, leukemia, Hodgkin's disease, malignant lymphomas, kidney cancer, 12 months in the case of other malignant tumors from completion of surgery, chemotherapy or radiotherapy;
- Suspected or diagnosed prostate or breast cancer in men;
- 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;
- Hypertensive crisis;
- liver impairment (AST and/or ALT > 3x normal: AST> 111 U/l and ALT> 123 U/l);
- Acute kidney injury and/or chronic kidney disease (stage G4 and G5);
- nephrotic syndrome, acute or chronic glomerulonephritis;
- advanced circulatory failure (NYHA stages III and IV);
- Acute and chronic respiratory failure requiring oxygen therapy;
- 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;
- 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 and hormonal drugs with anabolic effects other than nandrolone decanoate, • megestrol.
- Lack of informed consent for participation in the study.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Recruiting | 15 Feb 2023 | 168 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Injectio Natrii Chlorati Isotonica Polpharma, 9 mg/ml, rozpuszczalnik do sporządzania leków parenteralnych | Placebo | ROZPUSZCZALNIK DO SPORZĄDZANIA LEKÓW PARENTERALNYCH | INTRAMUSCULAR USE | 1 | 12 | PRD463376 |
Deca-Durabolin, 50 mg/ml, roztwór do wstrzykiwań | Test | ROZTWÓR DO WSTRZYKIWAŃ | INTRAMUSCULAR | 50 | 12 | PRD2175201 |