OsteonecrosisBONESNCT02598401
The British Osteonecrosis Study
An observational study of Osteonecrosis, run by University of Leeds at 4 sites in United Kingdom.
Trial summary
The aim of this research is to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma within the UK. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- observation
- How many people
- 50 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 21 Aug 2017to 10 Oct 2022
- Phase
- Observational
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, teenagers or young adults between the age of 10 (including the day of the 10th birthday)and 24 years 364 days (at the time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed under standard criteria are eligible for BONES.
Who may be able to join
- first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL)
Who cannot join
- inability to have MRI scans of lower limbs
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
Jessica Firkins, jessica.firkins@nhs.net
Jayashree Motwani
- Recruiting
Leeds Children's Hospital
Leeds, LS2 9NS
Martin Hemingway, 0113 3928776, martin.hemingway@nhs.net
Beki James
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
Stewart McConnell, 01132068465, Stewart.mcconnell@nhs.net
- Recruiting
Southampton Children's Hospital
Southampton, SO16 6YD
Ruth Lawrence, Ruth.Lawrence@uhs.nhs.uk
Shannon Cawte, shannon.cawte@uhs.nhs.uk
About this study
Official title: The British Osteonecrosis Study: A Prospective Multi-centre Study to Examine the Natural History of Osteonecrosis in Older Children, Teenagers and Young Adults With Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma
The aim of this research is to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma within the UK. In addition to using and validating new, internationally agreed, standard definitions for osteonecrosis, this study will provide the data needed to develop a radiological classification which correlates with clinical status.
Read the detailed description
Children, teenagers or young adults between the age of 10 (including the day of the 10th birthday) and 24 years 364 days (at the time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed under standard criteria are eligible for BONES.
The recruitment target is 50 over a 2 year period, which is based on an anticipated ascertainment target of 75%.
Information will be collected on basic demographics, presenting features and diagnosis at initial recruitment. Further data will be collected at the end of induction to ascertain treatment and response, along with results of relevant investigations performed in induction detailed below. Clinical information collected will include height, weight and puberty stage. At the four subsequent time points when MRI imagine is performed further data will also be collected, including a physiotherapy assessment using a structured assessment tool and child health assessment questionnaire, and biochemical information.
Investigations
The results of the following investigations, usually performed as part of the routine assessment, will be collected:
- At diagnosis - highest white cell count, immunophenotype, cytogenetics, molecular results; albumin; lipid profile; vitamin D level, PTH, bone profile
- At the end of induction - MRD result, flow cytometry from end of induction bone marrow; albumin; lipid profile plus results of additional investigations of vitamin D, PTH and bone profile if performed.
DEXA scans should be performed on all children >10y old and on treatment for ALL. It is recommended that a DEXA scan is performed at diagnosis and then annually. The results of these DEXA scans will be collected.
MRI of the hips, knees and ankles should comprise of unenhanced coronal T1 and STIR images as a minimum protocol. Knees and ankles can be imaged together. Where further information of a specific joint is needed pre-treatment additional sequences in different planes could be performed at the discretion of the participating centre. MRI will be performed at the following time points:
- Within 4 weeks of diagnosis
- At the end of delayed intensification
- One year after the start of maintenance
- Two years after the start of maintenance
- Three years after the start of maintenance
In the event of the development of osteonecrosis the patient should be managed according to local protocols and at the discretion of their own consultant. Information on treatment will be collected.
Radiological review:
A central review panel consisting of Paediatric Radiologists with an interest in paediatric haematology will meet quarterly to review each MRI in order to agree the grade of osteonecrosis and noting specific features according to the study radiology proforma.
- Conditions
- Osteonecrosis
- Being tested
- observation
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Observational study with no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of osteonecrosis
The incidence of osteonecrosis in older children, teenagers and young adults being treated for acute lymphoblastic leukaemia (ALL) in the UK at different time points in their treatment.
Measured: 5 years
Secondary outcomes (2)
Risk factors for development of osteonecrosis.
The risk factors for progression and the development of symptomatic osteonecrosis in this population.
Measured: 5 years
Radiological features for prediction of progression of osteonecrosis
specific radiological features that predict for either progression or regression in those with asymptomatic osteonecrosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start21 Aug 2017
- Primary completion10 Apr 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia laila Amin, University of Leeds
- Investigators
- Nadia L Amin, MBChB, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598401
- Sponsor's protocol ID
- 185365
- Acronym
- BONES
- Status last verified
- Apr 2019
- First submitted
- 4 Nov 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Amin N, Kinsey S, Feltbower R, Kraft J, Whitehead E, Velangi M, James B. British OsteoNEcrosis Study (BONES) protocol: a prospective cohort study to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma. BMJ Open. 2019 May 22;9(5):e027204. doi: 10.1136/bmjopen-2018-027204.
PubMed 31122988
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The British Osteonecrosis Study: A Prospective Multi-centre Study to Examine the Natural History of Osteonecrosis in Older Children, Teenagers and Young Adults With Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT02598401
- Acronym / sponsor ID
- BONES / 185365
- Conditions
- Osteonecrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 5 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.
The aim of this research is to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma within the UK. In addition to using and validating new, internationally agreed, standard definitions for osteonecrosis, this study will provide the data needed to develop a radiological classification which correlates with clinical status.
Detailed description
Children, teenagers or young adults between the age of 10 (including the day of the 10th birthday) and 24 years 364 days (at the time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed under standard criteria are eligible for BONES.
The recruitment target is 50 over a 2 year period, which is based on an anticipated ascertainment target of 75%.
Information will be collected on basic demographics, presenting features and diagnosis at initial recruitment. Further data will be collected at the end of induction to ascertain treatment and response, along with results of relevant investigations performed in induction detailed below. Clinical information collected will include height, weight and puberty stage. At the four subsequent time points when MRI imagine is performed further data will also be collected, including a physiotherapy assessment using a structured assessment tool and child health assessment questionnaire, and biochemical information.
Investigations
The results of the following investigations, usually performed as part of the routine assessment, will be collected:
- At diagnosis - highest white cell count, immunophenotype, cytogenetics, molecular results; albumin; lipid profile; vitamin D level, PTH, bone profile
- At the end of induction - MRD result, flow cytometry from end of induction bone marrow; albumin; lipid profile plus results of additional investigations of vitamin D, PTH and bone profile if performed.
DEXA scans should be performed on all children >10y old and on treatment for ALL. It is recommended that a DEXA scan is performed at diagnosis and then annually. The results of these DEXA scans will be collected.
MRI of the hips, knees and ankles should comprise of unenhanced coronal T1 and STIR images as a minimum protocol. Knees and ankles can be imaged together. Where further information of a specific joint is needed pre-treatment additional sequences in different planes could be performed at the discretion of the participating centre. MRI will be performed at the following time points:
- Within 4 weeks of diagnosis
- At the end of delayed intensification
- One year after the start of maintenance
- Two years after the start of maintenance
- Three years after the start of maintenance
In the event of the development of osteonecrosis the patient should be managed according to local protocols and at the discretion of their own consultant. Information on treatment will be collected.
Radiological review:
A central review panel consisting of Paediatric Radiologists with an interest in paediatric haematology will meet quarterly to review each MRI in order to agree the grade of osteonecrosis and noting specific features according to the study radiology proforma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, teenagers or young adults between the age of 10 (including the day of the 10th birthday)and 24 years 364 days (at the time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed under standard criteria are eligible for BONES.
Key inclusion criteria (1 listed)
- first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL)
Key exclusion criteria (1 listed)
- inability to have MRI scans of lower limbs
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 |
|---|---|---|
| observationObservational study with no intervention | Other | – |
Primary outcome
Incidence of osteonecrosis
Time frame: 5 years
The incidence of osteonecrosis in older children, teenagers and young adults being treated for acute lymphoblastic leukaemia (ALL) in the UK at different time points in their treatment.
2 secondary outcomes
Risk factors for development of osteonecrosis.
Time frame: 5 years
Radiological features for prediction of progression of osteonecrosis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 31122988Amin N, Kinsey S, Feltbower R, Kraft J, Whitehead E, Velangi M, James B. British OsteoNEcrosis Study (BONES) protocol: a prospective cohort study to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma. BMJ Open. 2019 May 22;9(5):e027204. doi: 10.1136/bmjopen-2018-027204.
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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.
Nadia L Amin, MBChB principal investigator
University of Leeds
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis, run by University of Leeds at 4 sites in United Kingdom.
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 1 inclusion and 1 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia L Amin, MBChB (0113 343 2596, nadia.amin3@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of osteonecrosis (time frame: 5 years). 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 NCT02598401, 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 17 Apr 2019.