Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial (LiFT)

ClinicalTrials.gov ID

NCT02999022

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

160Estimated

Last Update Posted

Jan 26, 2024Actual

Start Date

Jul 21, 2017Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Jun 2025Estimated

Official Title

Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

Brief Summary

This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can improve fracture healing and improve patients' function and productivity.

Detailed Description

Despite the success of traditional treatments for broken bones (surgery, immobilization, or both) 10% of fractures do not heal or take longer than normal to heal. This can have a significant effect on a patient's function and productivity, as well as on healthcare expenditures. Very few advances in fracture healing have been made, despite the need for new approaches to fracture treatment. This study proposes a simple, economical, and non-invasive approach to complement traditional fracture treatment that could decrease healing time and reduce the incidence of delayed healing. The investigators think that this can improve health outcomes for patients and reduce health care costs for the healthcare system in general. The goal is to see if a low-dose of Lithium treatment can have a positive effect on fracture healing and can reduce pain and improve function in patients who have broken a bone.

The LiFT study is a participant, surgeon and observer blinded single-centre randomized (1:1), controlled, superiority trial with 2 parallel groups. A minimization procedure will stratify participants based on the fractured long bone (clavicle, humerus, femur or tibia/fibula) and smoking.

Participants will be randomized to 1 of 2 groups: lithium capsules or placebo. The Lithium/placebo will be taken daily for 2 weeks, starting 2 weeks after the fracture occurs (or 2 weeks after surgery if the participant is treated with surgery).

• Fractures

• Lithium Carbonate
• Lactose Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Canadian Institutes of Health Research (CIHR)OTHER_GOV

gallaj4@mcmaster.ca

ashmanie.brijmohan@unityhealth.ca

• Evaluation of the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures

  NCT00552331

  CompletedInterventionalPhase 4Updated Jun 28, 2011
• Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing

  NCT07299851

  RecruitingInterventionalNot ApplicableUpdated Dec 23, 2025
• Low-level Laser Therapy in Distal Radius Fractures

  NCT03014024

  CompletedInterventionalNot ApplicableUpdated May 18, 2022
• Low-level Laser Therapy in Wrist Fractures

  NCT02749929

  CompletedInterventionalNot ApplicableUpdated Apr 30, 2021
• Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

  NCT05712616

  Unknown statusInterventionalPhase 4Updated Feb 3, 2023
• Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing

  NCT02786498

  CompletedInterventionalPhase 2Updated Mar 31, 2022