Nandrolone decanoate for Sarcopenia

Inclusion criteria

• {"criterion_text":"- Individuals aged 60 years or older through 99 years of age."}
• {"criterion_text":"- 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

• {"criterion_text":"- Mini-Mental State Examination (MMSE) score less than 19;"}
• {"criterion_text":"- nephrotic syndrome, acute or chronic glomerulonephritis;"}
• {"criterion_text":"- advanced circulatory failure (NYHA stages III and IV);"}
• {"criterion_text":"- Acute and chronic respiratory failure requiring oxygen therapy;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Lack of informed consent for participation in the study."}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Suspected or diagnosed prostate or breast cancer in men;"}
• {"criterion_text":"- acute and chronic inflammatory diseases of the gastrointestinal tract that present with malabsorption (celiac disease, ulcerative colitis, Crohn's disease, etc.);"}
• {"criterion_text":"- uncompensated hyper- or hypothyroidism;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Hypertensive crisis;"}
• {"criterion_text":"- liver impairment (AST and/or ALT > 3x normal: AST> 111 U/l and ALT> 123 U/l);"}
• {"criterion_text":"- Acute kidney injury and/or chronic kidney disease (stage G4 and G5);"}

Primary endpoints

• {"endpoint_text":"- Change in physical fitness as assessed by the SPPB test score (4- meter gait speed test version) in points, at the 5th study visit relative to the test score performed at visit 1","definition_or_measurement_approach":"Measured as change in SPPB test score (4-meter gait speed test version) in points between visit 1 and visit 5."}
• {"endpoint_text":"- Change in the 400-meter walk test score in time units, at the 5th test visit, relative to the test score taken at visit 1","definition_or_measurement_approach":"Measured as change in time to complete the 400-meter walk test between visit 1 and visit 5 (time units)."}

Poland

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

31-10-2024

Processing Time Days

38

Number Of Sites

1

Number Of Participants

168

Primary sponsor

Full Name

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Contract research organisations

Name

Ko-Med Centra Kliniczne Sp. z o.o.

Responsibilities

codes: 1,10,11,3,6,7,8,9

Third parties

• {"country":"Poland","full_name":"Ko-Med Centra Kliniczne Sp. z o.o.","duties_or_roles":"codes: 1,10,11,3,6,7,8,9","organisation_type":"Hospital/Clinic/Other health care facility"}