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New treatment option for Femoral Fracture
Official title Essential Amino Acid Supplementation for Femoral Fragility Fractures
ClinicalTrials.gov ID: NCT06050668
What this study is testing
What is Essential Amino Acid Supplementation?
Essential Amino Acid Supplementation is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for femoral fracture.
Also referred to as MEND Repair & Recover.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Hospital inpatient
- Age ≥ 65 years old on admission
- Low-energy mechanism of injury
- Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
- Indicated for surgical fixation
You likely can't join if
- Part of a vulnerable population (ex: Incarcerated, Non-English speaking)
- Cognitive impairment (MMSE score ≤ 17)
- Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps...
- Non-ambulatory prior to injury
- Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)
- Concern for inability to complete follow-up
See the full eligibility criteria
- Hospital inpatient
- Age ≥ 65 years old on admission
- Low-energy mechanism of injury
- Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
- Indicated for surgical fixation
- Able to provide informed consent
- Part of a vulnerable population (ex: Incarcerated, Non-English speaking)
- Cognitive impairment (MMSE score ≤ 17)
- Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)
- Non-ambulatory prior to injury
- Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)
- Concern for inability to complete follow-up
- Hemi or total arthroplasty (joint replacement)
- Patients with a historical diagnosis of chronic kidney disease (CKD)
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Eugene, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Eugene, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.