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FracturesPhase 2LiFTNCT02999022

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

A Phase 2 study testing Lithium Carbonate in people with Fractures, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Fractures
What is being tested?
Lithium Carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
5 sitesCanada
Study dates
21 Jul 2017to Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

Pujitha Rao contact

416-480-5627

lift@sunnybrook.ca

Mariam Saleem contact

Mariam.saleem@sunnybrook.ca

5 sites in 1 country

Canada5 sites, 5 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Kelly Cruise, 705-728-9090 ext. 45639, cruisek@rvh.on.ca

    Raaj Vora

    Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario

    Jodi Gallant, gallaj4@mcmaster.ca

    Jamal Al-Asiri

    Recruiting

  • The Ottawa Hospital Civic Campus

    Ottawa, Ontario, K1Y 4E9

    Steven Papp, MD, 613-737-8899 ext. 18131, spapp@toh.ca

    Melanie Dodd-Moher, 613-737-8899 ext. 19217, medodd@ohri.ca

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M5R 3P6

    Katrine Milner, 416-480-4285, katrine.milner@sunnybrook.ca

    BSc

    Recruiting

  • Unity Health St. Michael's Hospital

    Toronto, Ontario

    Ashmanie Brijmohan, ashmanie.brijmohan@unityhealth.ca

    Aaron Nauth

    Recruiting

Other trials in Canada

About this study

Official title: Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

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.

Read the 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).

Conditions
Fractures
Being tested
Lithium Carbonate, Lactose Placebo
Keywords
bone fractures, bony callus, fractures, bone, lithium, lithium carbonate, osteogenesis, bone development, fracture healing, fracture repair
Medical subject headings
Fractures, Bone, Callosities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium CarbonateDrug

    Also called Lithium

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

  • Lactose PlaceboDrug

    Also called placebo

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

Study groups in NCT02999022
Study groupRoleWhat they receive
Lithium carbonateExperimentalLithium carbonate 300mg capsule; once per day for 2 weeks.
Receives: Drug: Lithium Carbonate
Lactose placeboPlacebo comparatorLactose placebo capsule; once per day for 2 weeks.
Receives: Drug: Lactose Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiographic healing of fracture

    radiographic healing using the RUST score at 8 weeks

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

Secondary outcomes (6)

  1. radiographic union of fracture

    time to radiographic union using the RUST score

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

  2. 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

    Measured: 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)

  3. physical function

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

    Measured: 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)

  4. NSAID use

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

    Measured: 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)

  5. re-operation (after initial fracture management)

    surgery required after initial fracture management

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

  6. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study start21 Jul 2017
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999022
Sponsor's protocol ID
LiFT001
Acronym
LiFT
Status last verified
Jan 2024
First submitted
9 Sep 2016
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31915160

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lithium Carbonate in people with Fractures, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pujitha Rao (416-480-5627, lift@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiographic healing of fracture (time frame: 8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

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