SarcopeniaPhase 2SARKOPENIANCT05978206
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
A Phase 2 study testing Nandrolone Decanoate, Physiotherapy Intervention and Nutritional Intervention in people with Sarcopenia, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Nandrolone Decanoate, Physiotherapy Intervention and Nutritional Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 sitePoland
- Study dates
- 10 Aug 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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) 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).
Who cannot join
- 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, malignant lymphomas, kidney tumors, 12 months in the case of other malignant neoplasms after the completion of surgery, chemotherapy or radiotherapy;
- 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;
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- 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. 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 hormonal drugs with anabolic effects other than nandrolone decanoate,
- megestrol. 15. Lack of informed consent for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, 02-637
Marta Kurek, 603 315 033 ext. +48, marta.kurek@spartanska.pl
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Nandrolone Decanoate Therapy and Therapy With Complex Physiotherapy and Diet in the Treatment of Sarcopenia
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 ). Both groups will receive comprehensive physiotherapy and nutritional intervention.
Read more
There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule.
It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.
- Conditions
- Sarcopenia
- Being tested
- Nandrolone Decanoate, Physiotherapy Intervention, Nutritional Intervention, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nandrolone DecanoateDrug
Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo
Physiotherapy InterventionBehavioural
The physiotherapeutic intervention includes the following components:
- Strength training will include strength exercises 3 x a week x 30 min - load from 60% to 80% 1RM for individual muscle groups, - 10 repetitions of the exercise, - 1-3 series in 1 session (break between sessions 60 seconds).
- Endurance training will include aerobic exercises (cycle ergometer, treadmill, general fitness exercises) 3 times a week x 30 minutes, load from 60% to 80% of maximum heart rate.
Nutritional InterventionBehavioural
An individual diet in terms of calorific value and the content of energy substrates - proteins, fats and carbohydrates, as well as other nutrients, in accordance with specific nutrition standards.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Nandrolone | Experimental | Not described Receives: Drug: Nandrolone Decanoate; Behavioral: Physiotherapy Intervention; Behavioral: Nutritional Intervention |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Physiotherapy Intervention; Behavioral: Nutritional Intervention; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical fitness as assessed by the SPPB test score
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
Measured: in the 12th week of the study
Change in the 400-meter walk test score
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
Measured: in the 12th week of the study
Secondary outcomes (5)
lower limb muscle strength
lower limb muscle strength assessed with the result of the test of getting up 5 times from a chair per unit of time, upper limb muscle strength assessed with the result of the dynamometric handgrip test in kilograms during the 3rd and 5th visit of the examination in relation to the result made during the 1st visit
Measured: in the 6th and 12th week of the study
Respiratory muscle strength
Respiratory muscle strength assessed as a result of changes in airway pressures during inhalation and exhalation during the 5th visit of the study in relation to the result of the test performed at visit 1
Measured: in the 6th and 12th week of the study
muscle mass
muscle mass: assessed on the basis of the content of lean body mass of the upper and lower limbs in the study of body composition analysis using the electrical bioimpedance method; during the 3rd and 5th study visit in relation to the result of the study performed during visit 1
Measured: in the 6th and 12th week of the study
muscle mass of the upper and lower limbs
muscle mass of the upper and lower limbs: assessed on the basis of the content of lean body mass of the upper and lower limbs in the densitometry test during the 5th visit of the study in relation to the result of the test performed during visit 1
Measured: in the 6th and 12th week of the study
score of the Sarc-QoL quality of life questionnaire (validated Polish version)
score of the Sarc-QoL quality of life questionnaire (validated Polish version) during the 5th visit of the study in relation to the result of the study performed during visit 1
Measured: in the 6th and 12th week of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start10 Aug 2023
- Primary completion12 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Sponsor type
- Research network
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Tomasz Targowski, Prof. PhD, MD, Principal investigator, National Institute of Geriatrics, Rheumatology and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978206
- Sponsor's protocol ID
- NIGRIR_002SARKOPENIA
- Acronym
- SARKOPENIA
- Status last verified
- May 2025
- First submitted
- 28 Jul 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Nandrolone Decanoate Therapy and Therapy With Complex Physiotherapy and Diet in the Treatment of Sarcopenia
- ClinicalTrials.gov ID
- NCT05978206
- Acronym / sponsor ID
- SARKOPENIA / NIGRIR_002SARKOPENIA
- Conditions
- Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Collaborators
- Medical Research Agency, Poland
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ). Both groups will receive comprehensive physiotherapy and nutritional intervention.
There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule.
It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nandrolone | Experimental | Drug: Nandrolone Decanoate, Behavioral: Physiotherapy Intervention, Behavioral: Nutritional Intervention |
| Placebo | Placebo comparator | Behavioral: Physiotherapy Intervention, Behavioral: Nutritional Intervention, Drug: Placebo |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (15 listed)
- 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, malignant lymphomas, kidney tumors, 12 months in the case of other malignant neoplasms after the completion of surgery, chemotherapy or radiotherapy;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nandrolone DecanoatePatients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo | Drug | Nandrolone |
| Physiotherapy InterventionThe physiotherapeutic intervention includes the following components: 1. Strength training will include strength exercises 3 x a week x 30 min - load from 60% to 80% 1RM for individual muscle groups, - 10 repetitions of the exercise, - 1-3 series in 1 session (break between sessions 60 seconds). 2. Endurance training will include aerobic exercises (cycle ergometer, treadmill, general fitness exercises) 3 times a week x 30 minutes, load from 60% to 80% of maximum heart rate. | Behavioural | Nandrolone, Placebo |
| Nutritional InterventionAn individual diet in terms of calorific value and the content of energy substrates - proteins, fats and carbohydrates, as well as other nutrients, in accordance with specific nutrition standards. | Behavioural | Nandrolone, Placebo |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in physical fitness as assessed by the SPPB test score
Time frame: in the 12th week of the study
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
Change in the 400-meter walk test score
Time frame: in the 12th week of the study
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
5 secondary outcomes
lower limb muscle strength
Time frame: in the 6th and 12th week of the study
Respiratory muscle strength
Time frame: in the 6th and 12th week of the study
muscle mass
Time frame: in the 6th and 12th week of the study
muscle mass of the upper and lower limbs
Time frame: in the 6th and 12th week of the study
score of the Sarc-QoL quality of life questionnaire (validated Polish version)
Time frame: in the 6th and 12th week of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz Targowski, Prof. PhD, MD principal investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nandrolone Decanoate, Physiotherapy Intervention and Nutritional Intervention in people with Sarcopenia, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona Jannasz (226709188 ext. +48, iwona.jannasz@spartanska.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical fitness as assessed by the SPPB test score (time frame: in the 12th week of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.