Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07179042
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Intertrochanteric Femur Fracture
  • Muscle Atrophy

Eligibility Criteria

Sex
ALL
Age
60 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo tablets will be dispensed to the participants for 119-days.
  • Metformin — DRUG
    Metformin tablets will be dispensed to the participants for 119-days.

Study Details

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 Dates

Start date
Sep 4, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo tablets
    Encapsulated placebo tablets per day (dosage for days 1-7 following the surgery is 500 mg/day, days 8-13 is 1000 mg/day, days 14-119 is 1500 mg/day).
  • Experimental: Metformin tablets
    Encapsulated Metformin tablets per day (dosage for days 1-7 following the surgery is 500 mg/day, days 8-13 is 1000 mg/day, days 14-119 is 1500 mg/day).

Primary Outcome Measure

Mid-thigh size (MTS), (centimeters) [ Time Frame: 2-weeks after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah OrthopedicsSalt Lake CityUtah84108-

Find similar trials in Salt Lake City, UT

By research site
University of Utah Orthopedics· Salt Lake City, UT

Related Studies