NCT07179042

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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
52mo left

Started Sep 2025

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025Sep 2030

Study Start

First participant enrolled

September 4, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

September 10, 2025

Last Update Submit

April 23, 2026

Conditions

Intertrochanteric Femur FractureMuscle Atrophy

Keywords

Intertrochanteric Femur FractureMuscle AtrophyMetforminRandomizedDouble-blindPlacebo-controlled trial

Outcome Measures

Primary Outcomes (3)

  • Mid-thigh size (MTS), (centimeters)

    Mid-thigh circumference will be assessed in the participants. These tests will occur during the standard clinical follow-up visits at 2, 8, and 16 weeks. Each participant will have both legs assessed.

    2-weeks after surgery

  • Mid-thigh size (MTS), (centimeters)

    Mid-thigh circumference will be assessed in the participants. These tests will occur during the standard clinical follow-up visits at 2, 8, and 16 weeks. Each participant will have both legs assessed.

    8-weeks after surgery

  • Mid-thigh size (MTS), (centimeters)

    Mid-thigh circumference will be assessed in the participants. These tests will occur during the standard clinical follow-up visits at 2, 8, and 16 weeks. Each participant will have both legs assessed.

    16-weeks after surgery

Study Arms (2)

Placebo tablets

PLACEBO COMPARATOR

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).

Drug: Placebo

Metformin tablets

EXPERIMENTAL

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).

Drug: Metformin

Interventions

PlaceboDRUG

Placebo tablets will be dispensed to the participants for 119-days.

Placebo tablets
MetforminDRUG

Metformin tablets will be dispensed to the participants for 119-days.

Also known as: Glucophage, Glumetza, Riomet, Fortamet, and N,N-dimethylbiguanide
Metformin tablets

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Justin Haller, M.D.

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Randomized, double-blind, placebo-controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

September 4, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

US(1)