Status:
ENROLLING_BY_INVITATION
Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo
Lead Sponsor:
University of Utah
Conditions:
Intertrochanteric Femur Fracture
Muscle Atrophy
Eligibility:
All Genders
60-90 years
Phase:
EARLY_PHASE1
Brief Summary
The investigators central hypothesis is that metformin supplementation will be well-tolerated, safe, and provide patients with improved functional and muscle morphology outcomes following intertrochan...
Detailed Description
This study team investigates a patient population that undergoes muscle atrophy and falls under the current IND indication of metformin usage to prevent muscle atrophy and enhance muscle growth. The i...
Eligibility Criteria
Inclusion
- Age 60y and older.
- Displaced hip fracture (femoral neck, intertrochanteric femur, subtrochanteric femur fracture).
- Low energy mechanism of injury (ground level fall, etc).
- Operative treatment within 72 hours of injury.
- Previously ambulatory.
Exclusion
- History of kidney disease or failure (CKD \> stage 4; eGFR \< 45 mL/min/1.73m2).
- History of diabetes mellitus (HbA1c \> 6.5).
- Associated lower extremity fracture (ipsilateral or contralateral).
- Pathologic fracture.
- Presence of infection at the fracture site.
- History of metabolic bone disease (Pagets, etc.).
- Severe cognitive impairment (Six Item Screener with 3 or more errors).
- Stage 5 Parkinson's Disease.
- Open fracture.
- Risk of developing metformin-associated hypoglycemia (e.g., hepatic impairment (by history or screening laboratory assessment), presence of hypoglycemia at screening, history of adrenal or pituitary insufficiency, alcohol use disorder, subjects unable to maintain normal oral intake).
- Severe hepatic impairment (Child-Pugh C).
- Expected survival \< 6 months (based on clinical judgement).
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07179042
Start Date
September 4 2025
End Date
September 1 2030
Last Update
September 17 2025
Active Locations (1)
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1
University of Utah Orthopedics
Salt Lake City, Utah, United States, 84108