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

Primary Purpose

Fractures

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Lithium Carbonate

Lactose Placebo

About this trial

This is an interventional treatment trial for Fractures focused on measuring bone fractures, bony callus, fractures, bone, lithium, lithium carbonate, osteogenesis, bone development, fracture healing, fracture repair

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-55 years.
ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury.
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.
Fracture that is primarily closed or open fracture that has complete wound coverage.
Randomization ≤14 days from injury or surgery (for surgical patients).
Fractures treated surgically or nonsurgically by endochondral/secondary bone healing.
For surgical patients, surgery must be within 14 days of injury.

Exclusion Criteria:

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

Sites / Locations

Royal Victoria Regional Health CentreRecruiting
Hamilton Health SciencesRecruiting
The Ottawa Hospital Civic CampusRecruiting
Sunnybrook Health Sciences CentreRecruiting
Unity Health St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lithium carbonate

Lactose placebo

Arm Description

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

Lactose placebo capsule; once per day for 2 weeks.

Outcomes

Primary Outcome Measures

radiographic healing of fracture

radiographic healing using the RUST score at 8 weeks

Secondary Outcome Measures

radiographic union of fracture

time to radiographic union using the RUST score

visual analogue pain score

changes from baseline in participant-reported average pain in past week as measured on a visual analogue scale from 0-10 where 0 is no pain and 10 is extreme pain

physical function

changes in participant-reported function from baseline as measured on the RAND SF36 questionnaire

NSAID use

to track participant-reported use of non-steroidal anti-inflammatory medication and measure changes over the course of the study

re-operation (after initial fracture management)

surgery required after initial fracture management

adverse events

the number and type of adverse events occuring after the first dose of lithium/placebo and until the 6-week visit will be collected and reported according to local and national rules and regulations

Full Information

NCT ID

NCT02999022

First Posted

September 9, 2016

Last Updated

September 19, 2023

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT02999022

Brief Title

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

Acronym

LiFT

Official Title

Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 21, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fractures

Keywords

bone fractures, bony callus, fractures, bone, lithium, lithium carbonate, osteogenesis, bone development, fracture healing, fracture repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lithium carbonate

Arm Type

Experimental

Arm Description

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

Arm Title

Lactose placebo

Arm Type

Placebo Comparator

Arm Description

Lactose placebo capsule; once per day for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Lithium Carbonate

Other Intervention Name(s)

Lithium

Intervention Description

Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Intervention Type

Drug

Intervention Name(s)

Lactose Placebo

Other Intervention Name(s)

placebo

Intervention Description

Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Primary Outcome Measure Information:

Title

radiographic healing of fracture

Description

radiographic healing using the RUST score at 8 weeks

Time Frame

8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)

Secondary Outcome Measure Information:

Title

radiographic union of fracture

Description

time to radiographic union using the RUST score

Time Frame

4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants)

Title

visual analogue pain score

Description

changes from baseline in participant-reported average pain in past week as measured on a visual analogue scale from 0-10 where 0 is no pain and 10 is extreme pain

Time Frame

baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

Title

physical function

Description

changes in participant-reported function from baseline as measured on the RAND SF36 questionnaire

Time Frame

baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

Title

NSAID use

Description

to track participant-reported use of non-steroidal anti-inflammatory medication and measure changes over the course of the study

Time Frame

baseline then 3, 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 3, 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

Title

re-operation (after initial fracture management)

Description

surgery required after initial fracture management

Time Frame

4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

Title

adverse events

Description

the number and type of adverse events occuring after the first dose of lithium/placebo and until the 6-week visit will be collected and reported according to local and national rules and regulations

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-55 years. ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury. 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. Fracture that is primarily closed or open fracture that has complete wound coverage. Randomization ≤14 days from injury or surgery (for surgical patients). Fractures treated surgically or nonsurgically by endochondral/secondary bone healing. For surgical patients, surgery must be within 14 days of injury. Exclusion Criteria: Currently pregnant or breastfeeding. Any past or current malignancy that, in the opinion of an investigator, is not medically controlled. Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled. Autoimmune disease that, in the opinion of an investigator, is not medically controlled. Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled. Renal impairment based on clinical history. Past allergy or adverse reaction to Lithium. Lactose intolerance. Fractures surgically treated with absolute stability/primary bone healing. Isolated tibia or isolated fibula fracture. Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator. Inability to comply with study protocol, in the opinion of the investigator(s). Participation in another interventional clinical trial, at the discretion of the principal investigator. Use of concomitant ultrasound or other bone stimulation device.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pujitha Rao

Phone

416-480-5627

lift@sunnybrook.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Aman

sara.aman@sri.utoronto.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane Nam, MSc,MD,FRCSC

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Victoria Regional Health Centre

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly Cruise

Phone

705-728-9090

Ext

45639

cruisek@rvh.on.ca

Facility Name

Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jodi Gallant

gallaj4@mcmaster.ca

Facility Name

The Ottawa Hospital Civic Campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Papp, MD

Phone

613-737-8899

Ext

18131

spapp@toh.ca

First Name & Middle Initial & Last Name & Degree

Melanie Dodd-Moher

Phone

613-737-8899

Ext

19217

medodd@ohri.ca

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5R 3P6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Aman

sara.aman@sri.utoronto.ca

First Name & Middle Initial & Last Name & Degree

Katrine Milner, BSc

Phone

416-480-4285

katrine.milner@sunnybrook.ca

Facility Name

Unity Health St. Michael's Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashmanie Brijmohan

ashmanie.brijmohan@unityhealth.ca

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31915160

Citation

Nam D, Balasuberamaniam P, Milner K, Kunz M, Vachhani K, Kiss A, Whyne C. Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol. BMJ Open. 2020 Jan 7;10(1):e031545. doi: 10.1136/bmjopen-2019-031545.

Results Reference

derived

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

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