Study of the effectiveness of treatment of sarcopenia with the use of a medicinal product (nandrolone), comprehensive physiotherapy and diet.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

15 Mar 2023 → ongoing

Decision date (initial)

2024-10-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych

External identifiers

EU CT number

2024-517178-48-00

EudraCT number

2022-001987-82

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To evaluate the clinical efficacy of nandrolone pharmacotherapy in the treatment of sarcopenia.

Secondary objectives 3

1. analysis of inflammatory factors panel to select biomarkers of sarcopenia, ELISA tests - CRP, IL-1β, IL-1R, IL-2, IL-4, IL5, IL6, IL7, IL8, IL9, IL-10, IL-12, IL13, IL15, IL-17A, IL-6, IL-8, TNF-α, IFN-γ, TGF-β, GCSF, GM-CSF, AGE, VEGF, HIF-1A, MCP-1, β-catenin, IGF, NFκB, p53, SIRT1/3/6, Cox-2, PGE2, eNOS, leptin, vit. D, GDF-15, FGF, CCL2/3/4/5/11, CXCL, IP-10, PDGF, mTORC1, Foxo, MFI, SPARC, P3NP, CAF22, osteonectin, irisin, FABP3, cathepsin D;
2. microbiome and metabolome analysis of patients to determine the effectiveness of the applied pharmacotherapy, diet, physiotherapy;
3. analysis of the metabolome to identify biomarkers of sarcopenia.

Conditions and MedDRA coding

Sarcopenia is characterized by loss of the muscle mass and function. It develops with age and is associated with a high risk of functional loss in complex activities of daily living, deterioration and quality of life, falls and injuries, patient institutionalization, hospitalization, and mortality in older adults.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

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) 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 15

1. Mini-Mental State Examination (MMSE) score less than 19;
2. 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;
3. Suspected or diagnosed prostate or breast cancer in men;
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. Hypertensive crisis;
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 and hormonal drugs with anabolic effects other than nandrolone decanoate, • megestrol.
15. Lack of informed consent for participation in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Ul. Spartanska 1

City

Warsaw

Postcode

02-637

Country

Poland

Scientific contact point

Organisation

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

Contact name

Centrum Wsparcia Badań Klinicznych

Public contact point

Organisation

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

Contact name

Centrum Wsparcia Badań Klinicznych

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications