Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo (NCT07179042) | Clinical Trial Compass
By InvitationEarly Phase 1
Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo
United States60 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
Age range
60 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.