Lithium for Broken Bones

(LiFT Trial)

Recruiting at4 trial locations

Overseen by Diane Nam, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Lithium, Antipsychotics, Antiseizure

Disqualifiers: Pregnancy, Cancer, Renal impairment, others

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking Lithium, anti-psychotic, or anti-seizure medications.

Is lithium carbonate safe for human use?

The research articles provided do not contain specific safety information about lithium carbonate or its related names for human use. ^{1 2 3 4 5}

How does the drug Lithium Carbonate differ from other treatments for broken bones?

Lithium Carbonate is unique because it has been shown to affect bone biology, potentially causing bone loss, which is different from typical bone treatments that aim to strengthen or repair bone. While it is traditionally used for mood disorders, its impact on bone health is still being studied, making it a novel approach for bone-related conditions. ^{6 7 8 9 10}

Research Team

Diane Nam, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Inclusion Criteria

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

I am between 18 and 55 years old.

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

Exclusion Criteria

Participation in another interventional clinical trial, at the discretion of the principal investigator

I am currently on Lithium, anti-psychotic, or anti-seizure medication.

Lactose intolerance

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lithium or placebo capsules daily for 2 weeks, starting 2 weeks after fracture or surgery

2 weeks

Daily administration

Follow-up

Participants are monitored for safety, effectiveness, and adverse events after treatment

24 weeks

Visits at 3, 4, 6, 8, 12, and 24 weeks

Treatment Details

Interventions

• Lactose Placebo (Other)
• Lithium Carbonate (Mood Stabilizer)

Trial Overview 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.

Participant Groups

Group I: Lithium carbonate Experimental Treatment 1 Intervention

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

Group II: Lactose placebo Placebo Group 1 Intervention

Lactose placebo capsule; once per day for 2 weeks.

Lithium Carbonate is already approved in Canada, Japan for the following indications:

Approved in Canada as Lithium Carbonate for:

• Bipolar disorder

Approved in Japan as Lithium Carbonate for:

• Bipolar disorder

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Dr. Rajin Mehta

Sunnybrook Health Sciences Centre

Chief Medical Officer

MD from University of Toronto

Dr. Andrew J. Smith

Sunnybrook Health Sciences Centre

President and CEO since 2017

MD, MSc from University of Toronto; Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Findings from Research

Certain substances, including antimalarials and sulfonylureas, can cause serious and potentially fatal poisonings in toddlers even in small doses.

Early recognition and prompt management, including the use of antidotes and supportive care, are crucial in preventing severe outcomes from these poisonings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One pill can kill: assessing the potential for fatal poisonings in children. Matteucci, MJ.[2019]

A survey identified 33 cases of chemistry set poisoning in children, with one fatality and 13 recoveries, highlighting the significant risk associated with these sets, particularly due to inadequate packaging that was not child-resistant.

The study revealed that 42% of poisoning cases were linked to copper sulphate, and it led to recommendations for improved safety measures, including child-resistant containers and legal restrictions on toxic chemicals in chemistry sets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemistry set poisoning. Mucklow, ES.[2015]

This systematic report on Kudiezi injection compiles evidence from quality control, premarketing safety experiments, and postmarketing efficacy studies to assess its safety and effectiveness in clinical use.

The analysis aims to provide a comprehensive understanding of Kudiezi injection, highlighting the need for further research to ensure its safe application in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic report on re-evaluating kudiezi injection]. Liao, X., Hua, GQ., Xie, YM., et al.[2014]

In a study of 41 patients treated with colchicine over 20 years, 63.4% experienced either a complete response or improvement in their skin disease, indicating its efficacy.

Colchicine was found to have a favorable safety profile, with adverse events occurring rarely among the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of colchicine in inflammatory skin diseases: a retrospective, monocentric study in a large tertiary center. Anzengruber, F., Graf, V., Hafner, J., et al.[2021]

The study successfully synthesized lithium-silicate glass with 10 mol% Li2O using two different lithium precursors, lithium citrate and lithium nitrate, which resulted in distinct glass structures and properties.

Both types of synthesized materials (glass and glass-ceramic) were found to be safe for chondrocyte cells, showing no negative effects on cell viability or proliferation, making them promising candidates for cartilage regeneration applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lithium-silicate sol-gel bioactive glass and the effect of lithium precursor on structure-property relationships. Maçon, ALB., Jacquemin, M., Page, SJ., et al.[2022]

Lithium chloride (LiCl) significantly improved bone filling around titanium implants in estrogen-deficient rats, showing better results compared to the estrogen-deficient group at 20 and 30 days after implant placement.

In vitro, LiCl enhanced osteoblast-like cell activity by increasing mineralization and the expression of bone-related genes, indicating its potential to promote bone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lithium chloride improves bone filling around implants placed in estrogen-deficient rats. Posch, AT., de Avellar-Pinto, JF., Malta, FS., et al.[2020]

In a study involving 20 female rats with tibial bone defects, the lithium chloride-doped calcium phosphate cement (Li/CPC) significantly improved bone repair compared to the control cement, showing higher new bone volume and better structural integrity.

Li/CPC not only promoted faster bone healing, as evidenced by earlier formation of bone tissue, but also demonstrated superior osteoinductive properties, making it a promising option for enhancing bone defect repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of a lithium-doped calcium phosphate cement in promoting tibial bone defect repair in rats]. Li, L., Qin, YB., Ma, G., et al.[2018]

Lithium-doped biphasic calcium phosphate (BCP) can enhance the osteogenic properties of the material, with the optimal doping level identified as approximately 10 at%, which improves biological responses without causing instability.

Higher concentrations of lithium ions (above 10 at%) lead to crystal instability and do not further enhance the osteogenic behavior of human dental pulp stem cells, highlighting the importance of finding the right balance in lithium doping for effective medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lithium doped biphasic calcium phosphate: Structural analysis and osteo/odontogenic potential in vitro. Yoo, KH., Kim, Y., Kim, YI., et al.[2022]

In a study involving 10 female Wistar rats over 3 months, lithium carbonate was found to cause bone loss, indicating potential negative effects on bone health.

The study suggests that patients on long-term lithium therapy should be closely monitored for bone health, especially if they have additional risk factors for osteopenia, such as menopause or low calcium intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lithium carbonate on subchondral bone in sexually mature Wistar rats. Lewicki, M., Paez, H., Mandalunis, PM.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

One pill can kill: assessing the potential for fatal poisonings in children. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Chemistry set poisoning. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Systematic report on re-evaluating kudiezi injection]. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of colchicine in inflammatory skin diseases: a retrospective, monocentric study in a large tertiary center. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Lithium-silicate sol-gel bioactive glass and the effect of lithium precursor on structure-property relationships. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Lithium chloride improves bone filling around implants placed in estrogen-deficient rats. [2020]

8. China pubmed.ncbi.nlm.nih.gov

[Effect of a lithium-doped calcium phosphate cement in promoting tibial bone defect repair in rats]. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lithium doped biphasic calcium phosphate: Structural analysis and osteo/odontogenic potential in vitro. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Effect of lithium carbonate on subchondral bone in sexually mature Wistar rats. [2013]