Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isomyosamine 250mg, Placebo 250 mg.
- Who it may be relevant to
- Registry conditions: Sarcopenia in Elderly, Frailty, Frailty/Sarcopenia, Frailty in Older Adults. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Double Blind Placebo-Controlled Parallel Group Study Of Safety And Efficacy Of Isomyosamine In Treating Sarcopenia After Hip Or Femoral Fracture In Gerontological Population
Overview
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.
Interventions
- Drug Isomyosamine 250mg
Isomyosamine 250 mg capsules dosed 4 times daily - Drug Placebo 250 mg
Placebo 250 mg capsule 4 times daily
Primary outcome measures
- Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo [Time frame: From enrollment to the end of treatment at 90 days]
Secondary outcome measures (5)
- 4-meter walk test [Time frame: From enrollment to the end of treatment at 90 days]
- 6-minute walk test [Time frame: From enrollment to the end of treatment at 90 days]
- Grip strength [Time frame: From enrollment to the end of treatment at 90 days]
- Effect on serum levels of biochemical markers of TNF activation [Time frame: From enrollment to the end of treatment at 90 days]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in the Isomyosamine vs Placebo groups [Time frame: From enrollment to the end of treatment at 90 days]
Eligibility criteria
Inclusion criteria
- 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
- Body weight ≥35 kg
- Adequate dietary intake
- Potential subjects' intention to avoid reproductive activity will be confirmed
And one or more of the following criteria:
- Previous history frailty or sarcopenia diagnosis using standardized tests;
- Positive assessment for frailty or sarcopenia using standardized tests or as per clinician's judgement;
- Previous positive assessment for elevated biomarkers of inflammation (serum IL-6 level> LOQ, TNFR1 level > LOQ, and/or TNF-alpha level > LOQ)
Exclusion criteria
- 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)
- Newly (< 2 weeks) diagnosed COVID-19
- Inability or unwillingness to give written informed consent
- History of upper/lower respiratory tract infection, requiring systemic steroids, antibiotics, and or emergency room (ER) visit or urgent care within 6 weeks of screening visit
- History of adverse reaction or allergy to TNF inhibitor
- History of neurological, hepatic, renal, diabetic mellitus, thyroid disorder, psychiatric, addiction or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns per investigator discretion
- Currently under treatment by an anti-TNFα drug, such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and biosimilars
- Currently under treatment by an anti-diabetic medication, including glucagon-like peptide-1 (GLP-1) drugs such as semaglutide, or any of metformin, jenuvia, or insulin
- Unwillingness or inability to comply with study procedures, including smoking cessation
- History of epilepsy or seizure propensity, ataxia, abnormal EEG findings, abnormal brain magnetic resonance image, or other co-morbid neurological conditions
- Positive TB test
- Patients who are pregnant or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06942182 · TNF001