Simple Bone CystNCT02616757
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
A study testing Sunlight Omnisense Quantitative Ultrasound in people with Simple Bone Cyst, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Simple Bone Cyst
- What is being tested?
- Sunlight Omnisense Quantitative Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 6 Jan 2021
- Phase
- Interventional
- 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 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients ≥ 2 and ≤ 21 years
- Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
- 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.
- Patients ≥ 2 and ≤ 21 years
- 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.
- Patients ≥ 2 and ≤ 21 years
- Patients who have undergone any type of casting or surgical treatment for their fracture
- 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.
Who cannot join
- Patients with implants to stabilize the bone where the cyst is located.
- Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- Patients who are pregnant or breastfeeding
- Patients with a simple bone cyst crossing the growth plate
- Arm 2 - Healthy Controls
- Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
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- Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
- Patients who are pregnant or breastfeeding
- Arm 3 - Fracture patients
- Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
- Patients who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Simple Bone Cyst
- Being tested
- Sunlight Omnisense Quantitative Ultrasound
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunlight Omnisense Quantitative UltrasoundDevice
Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Simple Bone Cyst Patients | Active comparator | 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. Receives: Device: Sunlight Omnisense Quantitative Ultrasound |
| Fracture patients | Active comparator | 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. Receives: Device: Sunlight Omnisense Quantitative Ultrasound |
| Health volunteers | Placebo comparator | 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. Receives: Device: Sunlight Omnisense Quantitative Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-scores obtained using quantitative ultrasound
Measured: 2 years
Secondary outcomes (1)
Bone specific alkaline phosphatase
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startOct 2016
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Why it stopped: Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Bone CystStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Wright, The Hospital for Sick Children
- Investigators
- Andrew Howard, MD, Principal investigator, The Hospital for Sick ChildrenJames G. Wright, MD, Principal investigator, Nuffield Orthopaedic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616757
- Sponsor's protocol ID
- 1000049774
- Status last verified
- Apr 2021
- First submitted
- 25 Nov 2015
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
- ClinicalTrials.gov ID
- NCT02616757
- Acronym / sponsor ID
- 1000049774
- Conditions
- Simple Bone Cyst
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple Bone Cyst Patients | Active comparator | Device: Sunlight Omnisense Quantitative UltrasoundZ-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. |
| Fracture patients | Active comparator | Device: Sunlight Omnisense Quantitative UltrasoundZ-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. |
| Health volunteers | Placebo comparator | Device: Sunlight Omnisense Quantitative UltrasoundZ-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. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients ≥ 2 and ≤ 21 years
- Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
- 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.
- Patients ≥ 2 and ≤ 21 years
- 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.
Key exclusion criteria (12 listed)
- Patients with implants to stabilize the bone where the cyst is located.
- Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- Patients who are pregnant or breastfeeding
- Patients with a simple bone cyst crossing the growth plate
- Arm 2 - Healthy Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunlight Omnisense Quantitative UltrasoundUltrasound | Device | Fracture patients, Health volunteers, Simple Bone Cyst Patients |
Primary outcome
Z-scores obtained using quantitative ultrasound
Time frame: 2 years
1 secondary outcome
Bone specific alkaline phosphatase
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Howard, MD principal investigator
The Hospital for Sick Children
James G. Wright, MD principal investigator
Nuffield Orthopaedic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunlight Omnisense Quantitative Ultrasound in people with Simple Bone Cyst, run by The Hospital for Sick Children at 1 site 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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-scores obtained using quantitative ultrasound (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2021.