The British Osteonecrosis Study
BONES
1 other identifier
observational
50
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2022
CompletedApril 17, 2019
April 1, 2019
4.6 years
November 4, 2015
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
5 years
Secondary Outcomes (2)
Risk factors for development of osteonecrosis.
5 years
Radiological features for prediction of progression of osteonecrosis
5 years
Interventions
Observational study with no intervention
Eligibility Criteria
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.
You may qualify if:
- first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL)
You may not qualify if:
- \- inability to have MRI scans of lower limbs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
Leeds Children's Hospital
Leeds, LS2 9NS, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Southampton Children's Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 31122988DERIVED
Biospecimen
Samples will be obtained for future genetic analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia L Amin, MBChB
University of Leeds
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 5, 2015
Study Start
August 21, 2017
Primary Completion
April 10, 2022
Study Completion
October 10, 2022
Last Updated
April 17, 2019
Record last verified: 2019-04