Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet
Recruiting
Phase 2
Interventional Study
Sarcopenia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 60 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 168 (estimated)
- Sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Research network
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About This Trial
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)…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. individuals aged 60 years or older through 99 years of age.
2. 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
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Contacts