NCT05978206

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Network
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-08-10
• Primary completion: 2026-12-12
• Completion: 2026-12-30
• First posted: 2023-08-07
• Last updated: 2026-04-08

Locations

1 site across 1 country: Poland