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
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 99
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Poland
Centrum Wsparcia Badań Klinicznych
RECRUITING
Warsaw
Contact Information
Primary
Iwona Jannasz
iwona.jannasz@spartanska.pl
226709188
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 168
Treatments
Experimental: Nandrolone
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

This content was sourced from clinicaltrials.gov