Using Lithium to Improve Fracture Healing

Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

This study is testing if a low dose of Lithium can help people heal faster from fractures and get back to their normal activities.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 5 sites (Barrie, Ontario and 4 other locations)
• Trial ID: NCT02999022 on ClinicalTrials.gov

What this trial studies

This study investigates whether a low dose of Lithium can enhance the healing process of fractures and improve patient function and productivity. It addresses the issue of delayed healing in fractures, which affects a significant number of patients despite traditional treatments. The trial is a double-blind, randomized controlled design where participants will receive either Lithium capsules or a placebo for two weeks, starting two weeks after their fracture or surgery. The study aims to provide a simple and cost-effective approach to complement existing fracture treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 with specific types of diaphyseal fractures who are healthy prior to their injury.

Not a fit: Patients who are pregnant, breastfeeding, or have uncontrolled malignancies or metabolic bone diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce healing time and improve outcomes for patients with fractures.

How similar studies have performed: While few studies have explored the use of Lithium for fracture healing, this approach is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Age 18-55 years.
2. ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury.
3. Diaphyseal fracture of the humerus, femur or combined tibia/fibula (OTA diaphyseal subclass 2A or B), and clavicle (OTA diaphyseal subclass B1 or B2), with or without nerve injury.
4. Fracture that is primarily closed or open fracture that has complete wound coverage.
5. Randomization ≤14 days from injury or surgery (for surgical patients).
6. Fractures treated surgically or nonsurgically by endochondral/secondary bone healing.
7. For surgical patients, surgery must be within 14 days of injury.

Exclusion Criteria:

1. Currently pregnant or breastfeeding.
2. Any past or current malignancy that, in the opinion of an investigator, is not medically controlled.
3. Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled.
4. Autoimmune disease that, in the opinion of an investigator, is not medically controlled.
5. Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled.
6. Renal impairment based on clinical history.
7. Past allergy or adverse reaction to Lithium.
8. Lactose intolerance.
9. Fractures surgically treated with absolute stability/primary bone healing.
10. Isolated tibia or isolated fibula fracture.
11. Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator.
12. Inability to comply with study protocol, in the opinion of the investigator(s).
13. Participation in another interventional clinical trial, at the discretion of the principal investigator.
14. Use of concomitant ultrasound or other bone stimulation device.

Where this trial is running

Barrie, Ontario and 4 other locations

• Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (Recruiting)
• Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
• The Ottawa Hospital Civic Campus — Ottawa, Ontario, Canada (Recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• Unity Health St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Diane Nam, MSc,MD,FRCSC — Sunnybrook Health Sciences Centre
• Study coordinator: Pujitha Rao

Conditions Fractures; bone fractures; bony callus; fractures, bone; lithium; lithium carbonate; osteogenesis; bone development