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Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

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ClinicalTrials.gov Identifier: NCT02616757
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
James Wright, The Hospital for Sick Children

Brief Summary:
Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed.

Condition or disease Intervention/treatment Phase
Simple Bone Cyst Device: Sunlight Omnisense Quantitative Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
Study Start Date : October 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Simple Bone Cyst Patients

Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline and once annually for 2 years.

There will also be optional blood samples taken o measure bone alkaline phosphatase.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound

Active Comparator: Fracture patients

Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at future follow-up visits as clinically indicated or at a one year follow-up visit.

There will also be optional blood samples taken to measure bone alkaline phosphatase.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound

Placebo Comparator: Health volunteers

Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at a one year follow-up visit.

There will also be optional blood samples taken to measure bone alkaline phosphatase.

Device: Sunlight Omnisense Quantitative Ultrasound
Ultrasound




Primary Outcome Measures :
  1. Z-scores obtained using quantitative ultrasound [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Bone specific alkaline phosphatase [ Time Frame: 2 years ]


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.


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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Arm 1 - Simple Bone Cyst Patients

Inclusion Criteria

  1. Patients ≥ 2 and ≤ 21 years
  2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
  3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

  1. Patients with implants to stabilize the bone where the cyst is located.
  2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
  3. Patients who are pregnant or breastfeeding
  4. Patients with a simple bone cyst crossing the growth plate

Arm 2 - Healthy Controls

Inclusion Criteria

  1. Patients ≥ 2 and ≤ 21 years
  2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

  1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
  2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
  3. Patients who are pregnant or breastfeeding

Arm 3 - Fracture patients

Inclusion Criteria

  1. Patients ≥ 2 and ≤ 21 years
  2. Patients who have undergone any type of casting or surgical treatment for their fracture
  3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

  1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
  2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
  3. Patients who are pregnant or breastfeeding

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): NCT02616757


Contacts
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Contact: Julie Shiu, BSc 416-813-7654 ext 203156 julie.shiu@sickkids.ca
Contact: Magdalena Lysenko, MSc 416-813-7654 ext 202959 magdalena.lysenko@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Julie Shiu, BSc    416-813-7654 ext 203156    julie.shiu@sickkids.ca   
Contact: Magdalena Lysenko, MSc    416-813-7654 ext 202959    magdalena.lysenko@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Andrew Howard, MD The Hospital for Sick Children
Principal Investigator: James G. Wright, MD Nuffield Orthopaedic Centre
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Responsible Party: James Wright, Orthopaedic Surgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02616757    
Other Study ID Numbers: 1000049774
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Cysts
Bone Cysts
Neoplasms
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases