The British Osteonecrosis Study

Osteonecrosis Clinical Trial

— BONES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598401
• Other study ID #: 185365
• Status: Recruiting
• Start date: August 21, 2017
• Est. completion date: October 10, 2022

Study information

• Verified date: April 2019
• Source: University of Leeds
• Contact: Nadia L Amin, MBChB
• Phone: 0113 343 2596
• Email: nadia.amin3[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. At diagnosis - highest white cell count, immunophenotype, cytogenetics, molecular results; albumin; lipid profile; vitamin D level, PTH, bone profile

2. 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:

1. Within 4 weeks of diagnosis

2. At the end of delayed intensification

3. One year after the start of maintenance

4. Two years after the start of maintenance

5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 10, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL)

Exclusion Criteria:

• inability to have MRI scans of lower limbs

Related Conditions & MeSH terms

• Osteonecrosis

Intervention

Other:
• observation
Observational study with no intervention

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Leeds Children's Hospital	Leeds
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Southampton Children's Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors for development of osteonecrosis.	The risk factors for progression and the development of symptomatic osteonecrosis in this population.	5 years
Secondary	Radiological features for prediction of progression of osteonecrosis	specific radiological features that predict for either progression or regression in those with asymptomatic osteonecrosis	5 years

External Links

•   British OsteoNEcrosis study website