Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet

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).

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.

Conditions

• Sarcopenia

Interventions

DRUG

Nandrolone Decanoate

Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo

BEHAVIORAL

Physiotherapy Intervention

The 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.

BEHAVIORAL

Nutritional Intervention

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.

DRUG

Placebo

Placebo

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

  lead NETWORK

Principal Investigators

• Tomasz Targowski, Prof. PhD, MD · National Institute of Geriatrics, Rheumatology and Rehabilitation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-10

Primary Completion

2026-12-12

Completion

2026-12-30

Countries

• Poland

Study Locations