Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo
Enrolling by invitation · Early Phase 1 · Has a placebo group
Conditions studied: Intertrochanteric Femur Fracture, Muscle Atrophy
In brief
The investigators central hypothesis is that metformin supplementation will be well-tolerated, safe, and provide patients with improved functional and muscle morphology outcomes following intertrochanteric femur fracture. The objectives will be tested in older adults that sustain a hip fracture and are randomized to receive a daily oral dose (1.5g daily) of metformin or a non-active placebo during 4 months of recovery following surgery.
Key facts
- Study ID
- NCT07179042
- Run by
- University of Utah
- People needed
- 60
- Starts
- 2025-09-04
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-04-29
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- University of Utah Orthopedics — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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