The British Osteonecrosis Study (BONES)

April 16, 2019 updated by: Nadia laila Amin, University of Leeds

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Not yet recruiting
        • Birmingham Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jayashree Motwani
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Contact:
      • Leeds, United Kingdom, LS2 9NS
        • Recruiting
        • Leeds Children's Hospital
        • Contact:
        • Principal Investigator:
          • Beki James
      • Southampton, United Kingdom, SO16 6YD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for development of osteonecrosis.
Time Frame: 5 years
The risk factors for progression and the development of symptomatic osteonecrosis in this population.
5 years
Radiological features for prediction of progression of osteonecrosis
Time Frame: 5 years
specific radiological features that predict for either progression or regression in those with asymptomatic osteonecrosis
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Investigators

  • Principal Investigator: Nadia L Amin, MBChB, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Anticipated)

April 10, 2022

Study Completion (Anticipated)

October 10, 2022

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 185365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteonecrosis

Clinical Trials on observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe