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Evaluation of nandrolone decanoate treatment combined with physiotherapy and diet in elderly patients with sarcopenia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on sarcopenia, a condition characterized by the loss of muscle mass and function that typically develops with age. This condition can lead to difficulties in performing daily activities, increased risk of falls, and reduced quality of life in older adults. The study will evaluate a treatment combining nandrolone decanoate (also known as Deca-Durabolin) with comprehensive physical therapy and dietary modifications.

The research aims to determine how effective nandrolone therapy is in treating sarcopenia when combined with exercise and diet. During the study, participants will receive either intramuscular injections of nandrolone or a placebo, along with physical therapy and dietary guidance. The treatment period will last for 12 months.

The study will measure improvements in physical fitness through walking tests and other physical performance measures. This research is particularly important for understanding how to better manage muscle loss in older adults and potentially improve their overall function and independence in daily activities.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study entry</b>

    The clinical trial begins with an initial assessment to establish a baseline for physical fitness. this includes the sppb test, which is a 4-meter walk speed test, and a 400-meter walk test.

  2. Step 2

    <b>medication administration</b>

    One of two types of intramuscular injections (medicine injected into the muscle) will be administered. either the test medication, which is nandrolone decanoate at a dose of 50 mg, or a placebo, which is a sodium chloride solution (salt water) at a dose of 1 ml.

    The treatment is part of a program that also includes physiotherapy (physical exercises to improve movement) and a specific diet.

  3. Step 3

    <b>monitoring and follow-up</b>

    Regular visits occur to monitor the effects of the treatment on sarcopenia, which is the loss of muscle mass and strength.

    At the 5th study visit, the sppb test (4-meter walking speed) and the 400-meter walk test are repeated to measure changes in physical fitness compared to the first visit.

Who can join the trial?

4 criteria

  • You must be between 60 and 99 years old.
  • You must have a diagnosis of sarcopenia, which is a condition where a person loses muscle mass and muscle strength.
  • You must show signs of muscle weakness, which is measured by one of two ways: having low strength when squeezing a hand-held device called a hand dynamometer (less than 27 kg for men and 16 kg for women), or having difficulty performing a chair rise test (taking longer than 15 seconds to stand up from a chair 5 times).
  • You must have a reduction in muscle mass, which is measured by one of the following: a low muscle density measurement, having a total muscle mass in the arms and legs that is less than 20 kg for men or less than 15 kg for women, or having a low amount of skeletal muscle mass (the muscles used for movement) as shown by a bioelectrical impedance (BIA) test, which is a medical scan that uses a small electrical current to estimate body composition.

Who cannot join the trial?

17 criteria

  • A score of less than 19 on the Mini-Mental State Examination, which is a test used to measure mental sharpness and memory.
  • Having nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine) or glomerulonephritis (inflammation of the tiny filters in the kidneys).
  • Having advanced circulatory failure, specifically stages III or IV of the NYHA scale, which describes how much heart problems limit your physical activity.
  • Having acute or chronic respiratory failure, which means your lungs are not providing enough oxygen to the body, requiring the use of oxygen therapy.
  • Having specific muscle or nerve diseases, such as Amyotrophic lateral sclerosis (a disease that affects nerve cells in the brain and spinal cord), multiple sclerosis (a disease affecting the central nervous system), myasthenia gravis (a condition that causes weakness in muscles), dystrophies (muscle wasting diseases), spinal muscular atrophy, or other myopathies (diseases that affect muscle tissue).
  • Having epilepsy (a condition that causes recurring seizures).
  • The need for certain medications during the study, including systemic corticosteroids (strong anti-inflammatory drugs) used for more than 3 weeks, hormone replacement therapy, 5-alpha reductase inhibitors, aromatase inhibitors, other hormonal drugs with muscle-building effects, or megestrol.
  • The inability to provide informed consent, which is the official agreement to participate in the study after understanding all the details.
  • Having a malignant tumor (cancer) or blood-related diseases like leukemia, lymphoma, or myeloproliferative diseases that require cancer treatment, specifically if it has been less than 5 years since certain cancers (like prostate or kidney cancer) or less than 12 months since other cancers were treated.
  • Having suspected or diagnosed prostate or breast cancer in men.
  • Having inflammatory diseases of the gastrointestinal tract that cause malabsorption (when the body cannot properly soak up nutrients from food), such as celiac disease, ulcerative colitis, or Crohn's disease.
  • Having uncompensated hyperthyroidism or hypothyroidism (conditions where the thyroid gland is either too active or not active enough, and the body is not managing the imbalance).
  • Having a recent myocardial infarction (heart attack) or stroke within the last 4 weeks.
  • Having a history of thromboembolism (blood clots that move through the bloodstream) within the last 6 months or having recurring blood clots.
  • Having a hypertensive crisis (a sudden, severe increase in blood pressure).
  • Having liver impairment, which is shown by high levels of liver enzymes known as AST and ALT in a blood test.
  • Having acute kidney injury or chronic kidney disease at advanced stages (stage G4 or G5).
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Investigated drugs

Nandrolone decanoate is an injectable medication used to test its effectiveness in treating sarcopenia, which is the loss of muscle mass and strength. It is being studied to see if it can help improve muscle conditions.

What is already known about the treatment

  • Sodium chloride

    This substance is a simple salt solution administered as an injection into the muscle to act as a placebo in this study. It is widely used in medicine as a liquid to dissolve other drugs or to balance fluids in the body. It does not have a specific therapeutic effect for muscle loss but serves as a neutral comparison point. This solution belongs to a group of substances used as solvents and diluting agents.

  • Nandrolone decanoate

    This medication is an injectable solution administered into the muscle to help treat the loss of muscle mass and strength. It is a known anabolic steroid that works by attaching to specific receptors in the body to promote muscle growth and bone density. In medical practice, it is used to support muscle building and recovery in certain conditions. It is classified as an androgenic anabolic steroid.

Investigated diseases

Sarcopenia - This condition involves the progressive loss of muscle mass and strength. It typically develops as a person gets older. As it advances, it can lead to a decline in the ability to perform everyday physical tasks. The loss of muscle function may also affect overall physical stability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517178-48-00Protocol codeNIGRIR_002SARKOPENIAEstimated enrolment168 patientsSponsorNarodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

sourced from the EU Clinical Trials Register and site verification

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