This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness. Isomyosamine is a promising oral medication that reduces inflammation by targeting cytokines like TNF-α and IL-6, which are linked to these conditions. Previous studies have shown it is well-tolerated and may help improve muscle strength, mobility, and healing after hip fractures. This trial aims to determine its potential benefits in reducing inflammation and improving recovery in elderly patients.
Age 60 to 85 years of age
Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall
Concomitant medication limited to treatment for chronic conditions
The ability to give informed consent and comply with study procedures
Receiving immunotherapy for cancer or solid organ transplantation
Complex or comminuted fracture or fracture of multiple long bones
Regular treatment for chronic disease including chronic renal failure, chronic heart failure (CHF) cerebrovascular disease including stroke, rheumatoid arthritis, or polymyalgia rheumatica
Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min)
Parallel
Isomyosamine 250mg
DrugIsomyosamine 250 mg capsules dosed 4 times daily
Placebo 250 mg
DrugPlacebo 250 mg capsule 4 times daily
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
4-meter walk test
Change in the time taken to walk 4 meters through 90 days dosing.
6-minute walk test
Change in the distance walked in the 6-minute walk test (m) through 90 days dosing.
Grip strength
Change in grip strength score over 90 day dosing.
Effect on serum levels of biochemical markers of TNF activation
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This trial is not recruiting at the moment. You can still explore other options:
