Metformin for Hip Fracture Recovery

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Disqualifiers: Diabetes, Kidney disease, Severe cognitive impairment, others

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether metformin, a common diabetes medication, can improve recovery after hip fracture surgery. Researchers aim to determine if it helps patients regain strength and function during recovery. Participants will receive either metformin or a placebo (a pill with no active ingredients) for four months post-surgery. The trial seeks older adults who recently underwent surgery for a hip fracture caused by a fall and were able to walk before their injury. As an Early Phase 1 trial, this research focuses on understanding how metformin works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin is generally safe for people. Several studies suggest that metformin use can lower the risk of bone fractures. One study found that it reduced the chance of hip fractures in those who took it. Another study showed that metformin does not increase the risk of hip fractures and might even help bones heal faster by improving blood flow.

In summary, evidence suggests that metformin is well-tolerated and does not pose major safety concerns. This should reassure anyone considering joining a trial involving metformin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hip fracture recovery?

Unlike the standard treatments for hip fracture recovery, which typically focus on pain management and physical therapy, Metformin presents a unique approach by potentially enhancing bone healing and reducing inflammation. Researchers are excited about Metformin because it is traditionally a diabetes medication, which means it works by improving insulin sensitivity and may also promote cellular repair processes in bones. This could lead to faster and more effective recovery for patients with hip fractures, offering a novel benefit beyond what current treatments provide.

What evidence suggests that metformin might be an effective treatment for hip fracture recovery?

Studies have shown that metformin, which participants in this trial may receive, can support bone health and may lower the risk of fractures. In some studies with mice, metformin helped bones heal faster, offering promise for humans as well. Research also indicates that metformin can aid muscle recovery after a hip fracture, potentially helping older adults recover more quickly and effectively after hip surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Justin Haller, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for older adults who have recently had surgery for a hip fracture. Participants will be given either metformin or a placebo daily for 4 months to see if it helps with muscle recovery and function.

Inclusion Criteria

I am 60 years old or older.

My injury was caused by a low-energy event, like falling from standing.

I have a broken hip bone.

Exclusion Criteria

I do not have advanced kidney disease (my kidney function is above stage 4).

I have diabetes with an HbA1c level over 6.5.

I have a fracture in my leg on the same or opposite side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either metformin or placebo for muscle recovery following hip fracture surgery

16 weeks

Standard clinical follow-up visits at 2, 8, and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview

The study is testing whether taking metformin (1.5g daily) improves the outcome of patients recovering from hip fractures compared to those taking a non-active placebo, focusing on muscle and functional recovery over four months.

How Is the Trial Designed?

Group I: Metformin tablets Experimental Treatment 1 Intervention

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).

Group II: Placebo tablets Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9874692/

Association of metformin use with fracture risk in type 2 diabetes

According to the data we collected in the 11 studies, four studies revealed that metformin treatment could reduce fracture risk (45, 50, 52, 54) ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07179042

Intertrochanteric Femur Fracture Patients Who Receive ...

The investigators are now proposing to utilize metformin as a novel tool to enhance muscle recovery following a hip fracture in older adults.

3.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06493-9

The use of metformin, sulfonylurea compounds and insulin ...

The results of this study showed that taking metformin reduces the risk of hip fracture, and insulin and Sulfonylurea increase the risk of hip fracture.

4.

nature.com

nature.com/articles/s41413-023-00279-4

Metformin accelerates bone fracture healing by promoting ...

Here, we show that metformin accelerated fracture healing in both osteoporotic and normal mice. Moreover, metformin promoted angiogenesis in ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168822722008981

Associations between presence of diabetes, mortality and ...

Outcomes after hip surgery. Our primary outcome was all-cause mortality after hip fracture diagnosis. Secondary outcomes included length of hospital stay and ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S8756328220301058

Metformin therapy and hip fracture risk among patients with ...

This population-based cohort study in South Korea showed that there was no significant association between the exposure to metformin therapy and hip fracture.