ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    Recruiting, Not yet recruiting, Available Studies | "Callosities"

Lithium for Fracture Treatment (LiFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02999022
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Fractures Drug: Lithium Carbonate Drug: Lactose Placebo Phase 2

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 (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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lithium for Fracture Treatment: a Double Blind Randomized Control Trial
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Lithium carbonate
Lithium carbonate 300mg capsule; once per day for 2 weeks.
Drug: Lithium Carbonate
Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.
Other Name: Lithium

Placebo Comparator: Lactose placebo
Lactose placebo capsule; once per day for 2 weeks.
Drug: Lactose 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.
Other Name: placebo




Primary Outcome Measures :
  1. radiographic healing of fracture [ Time Frame: 8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants) ]
    radiographic healing using the RUST score at 8 weeks


Secondary Outcome Measures :
  1. radiographic union of fracture [ Time Frame: 4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants) ]
    time to radiographic union using the RUST score

  2. 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) ]
    changes in participant-reported pain from baseline as measured on a visual analogue scale (VAS)

  3. physical function [ 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) ]
    changes in participant-reported function from baseline as measured on the RAND SF36 questionnaire

  4. NSAID use [ 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) ]
    to track participant-reported use of non-steroidal anti-inflammatory medication and measure changes over the course of the study

  5. re-operation (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) ]
    surgery required after initial fracture management

  6. adverse events [ Time Frame: 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-55 years
  2. ASA (American Society of Anesthesiologists) ≤ 2 class (healthy)
  3. Closed or open mid-shaft fractures of the humerus, femur, or tibia/fibula (OTA diaphyseal subclass 2A of B), with or without nerve injury
  4. Soft tissue injury of grade 0, 1, or 2 of the Tscherne classification
  5. Fracture date ≤14 days before randomization
  6. Fracture treated surgically or non-surgically
  7. For surgical patients, surgery must be ≤72 hours of injury

Exclusion Criteria:

  1. Currently pregnant or breastfeeding
  2. Any past or current malignancy
  3. Metabolic bone disease based on clinical history
  4. Autoimmune disease
  5. Hypothyroidism based on clinical history
  6. Renal impairment based on clinical history
  7. Past allergy or adverse reaction to Lithium
  8. Lactose intolerance
  9. Inability to comply with study protocol, in the opinion of the investigators
  10. Fractures surgically treated with absolute stability/primary bone healing
  11. Tibia fractures with intact fibula
  12. Currently taking Lithium or anti-psychotic or anti-seizure medication for any reason {These include: phenothiazine/thioridazine, haloperidol (Haldol), carbamazepine, phenytoin (Dilantin)}

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999022


Contacts
Contact: Monica R Kunz, BA, CCRP 416-480-4285 monica.kunz@sunnybrook.ca
Contact: Katrine Milner, BSc, ACRP 416-480-4285 katrine.milner@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M5R 3P6
Contact: Monica R Kunz, BA    416-480-4285    monica.kunz@sunnybrook.ca   
Contact: Katrine Milner, BSc    416-480-4285    katrine.milner@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Diane Nam, MSc,MD,FRCSC Sunnybrook Health Sciences Centre

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02999022     History of Changes
Other Study ID Numbers: LiFT001
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sunnybrook Health Sciences Centre:
bone fractures
bony callus
fractures, bone
lithium
lithium carbonate
osteogenesis
bone development
fracture healing
fracture repair

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs