Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978206
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-07-28
Brief Title:
Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product Nandrolone Comprehensive Physiotherapy and Diet
Sponsor:
National Institute of Geriatrics Rheumatology and Rehabilitation Poland
Organization:
National Institute of Geriatrics Rheumatology and Rehabilitation Poland
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARKOPENIA
Brief 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 11 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 70 kgm2 height in men and 55 kgm2 in women or total muscle mass of the upper and lower extremities 20 kg in men and 15 kg in women by densitometry
Patients will be randomized 11 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 70 kgm2 height in men and 55 kgm2 in women or total muscle mass of the upper and lower extremities 20 kg in men and 15 kg in women by densitometry
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None