BridgeMD
Study of the effectiveness of treatment of sarcopenia with the use of a medicinal product (nandrolone), comprehensive physiotherapy and diet.
EU CTIS ID: 2024-517178-48-00
What this study is testing
To evaluate the clinical efficacy of nandrolone pharmacotherapy in the treatment of sarcopenia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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) 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.
You likely can't join if
- Mini-Mental State Examination (MMSE) score less than 19;
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Mini-Mental State Examination (MMSE) score less than 19;
- 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.
- 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);
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.