What side effects are associated with this type of intervention?

Common treatments for broken bones, such as bisphosphonates, can cause gastrointestinal issues, musculoskeletal pain, and, in rare cases, osteonecrosis of the jaw and atypical femoral fractures. Lithium, which is being studied for its potential to enhance bone healing, has side effects including tremor, increased drinking, diarrhea, and subclinical hypothyroidism.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of osteoporosis and bone fractures that promote bone formation and reduce bone resorption. Notably, teriparatide (PTH 1-34) is an anabolic agent that stimulates bone formation and is used for severe osteoporosis. Denosumab, another FDA-approved drug, works by inhibiting osteoclasts, thereby reducing bone resorption. Romosozumab, which has shown efficacy in increasing bone mineral density and reducing fractures, also promotes bone formation while inhibiting bone resorption. These treatments are similar to the mechanisms being studied in the lithium trial for fracture healing.

What other types of research exist?

Promising novel alternatives to Lithium for bone healing include: 1) Romosozumab, which has shown efficacy in reducing vertebral and nonvertebral fractures by promoting bone formation and reducing resorption. 2) Teriparatide, an anabolic agent that stimulates bone formation and is effective in severe osteoporosis cases. 3) Denosumab, which reduces bone resorption and is an option for patients who cannot tolerate bisphosphonates. These alternatives have demonstrated positive outcomes in clinical trials and are viable options for bone healing treatment in 2024.

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Mood Stabilizer

Lithium for Broken Bones (LiFT Trial)

Phase 2

Recruiting

Led By Diane Nam, MSc,MD,FRCSC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fracture that is primarily closed or open fracture that has complete wound coverage

Age 18-55 years

Must not have

Isolated tibia or isolated fibula fracture

Fractures surgically treated with absolute stability/primary bone healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

Summary

This trial is testing if taking a small amount of Lithium for a short period can help broken bones heal faster and better. It targets patients whose fractures are not healing well with traditional treatments. Lithium might help bones repair themselves more quickly by enhancing the natural healing process. Lithium, commonly used in psychiatric medicine, has shown potential in enhancing bone healing.

Who is the study for?

The LiFT trial is for healthy adults aged 18-55 with certain types of broken bones (humerus, femur, tibia/fibula, clavicle) that can heal on their own or after surgery. Participants must not have uncontrolled diseases like cancer or autoimmune disorders, be pregnant/breastfeeding, lactose intolerant, have renal issues or past bad reactions to Lithium.

What is being tested?

This study tests if a low dose of Lithium Carbonate over two weeks helps bone fractures heal better compared to a Lactose Placebo. It's double-blind meaning neither the patients nor the researchers know who gets the real treatment versus placebo until after results are collected.

What are the potential side effects?

While not specified here, common side effects of Lithium may include increased thirst and urination, nausea and general discomfort in the stomach area. More serious but less common side effects could involve changes in heart rhythm or thyroid function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My fracture is either fully closed or, if open, the wound is completely covered.

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I am between 18 and 55 years old.

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I was injured or had surgery less than 14 days ago.

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I have a mid-shaft fracture in my arm, leg, or collarbone, possibly with nerve damage.

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My surgery is scheduled within 14 days of my injury.

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I have had a fracture that was treated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a broken tibia or fibula, but no other injuries.

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My fracture was fixed surgically and is healing without movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

radiographic healing of fracture

Secondary study objectives

Anti-Inflammatory Agents, Non-Steroidal

adverse events

physical function

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lithium carbonateExperimental Treatment1 Intervention

Lithium carbonate 300mg capsule; once per day for 2 weeks.

Group II: Lactose placeboPlacebo Group1 Intervention

Lactose placebo capsule; once per day for 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lithium Carbonate

2008

Completed Phase 4

~1270

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for broken bones include anabolic agents and bisphosphonates. Anabolic agents, such as teriparatide, work by stimulating bone formation through the activation of osteoblasts, which are cells responsible for new bone synthesis. This is crucial for patients with broken bones as it accelerates the healing process by enhancing bone regeneration. Bisphosphonates, on the other hand, reduce bone resorption by inhibiting osteoclasts, the cells that break down bone tissue. This dual approach of promoting bone formation and reducing bone resorption helps in maintaining bone density and strength, thereby facilitating effective fracture healing and reducing the risk of future fractures.

Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial.Mechanisms Underlying Normal Fracture Healing and Risk Factors for Delayed Healing.