The British Osteonecrosis Study

2015-11-08 17:59:51 | BioPortfolio


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.


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 200 over a 3 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 Tanner 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.


No biological samples are required, but 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

2. At the end of induction - MRD result, flow cytometry from end of induction bone marrow; albumin; lipid profile

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 2 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 Design

Observational Model: Cohort, Time Perspective: Prospective






Leeds Children's Hospital
United Kingdom


Not yet recruiting


University of Leeds

Results (where available)

View Results


Published on BioPortfolio: 2015-11-08T17:59:51-0500

Clinical Trials [212 Associated Clinical Trials listed on BioPortfolio]

Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and a...

Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties.The investigators will infuse expanded autologous MSC into patients with osteonecrosis of the ...

Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip

Several risk factors for the development of osteonecrosis of the femoral head following treatment of developmental dislocated hip have been reported. The need for further research with a l...

Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip

The purpose of this study is to determine if prolonged administration of low-dose aspirin will prevent the progression of early-stage osteonecrosis of the femoral head and may even reduce ...

Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible

Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated in two groups randomly : In group1, 10 patients underwent debridement and primary closer of the ...

PubMed Articles [1509 Associated PubMed Articles listed on BioPortfolio]

Patellar Osteonecrosis Following Knee Arthroscopy.

Patellar osteonecrosis is a rare condition, although knee osteonecrosis has been described in the arthroplasty literature. This is the first case describing knee arthroscopy as the cause of osteonecro...

Long-Term Survivorship of Total Hip Arthroplasty with Highly Cross-Linked Polyethylene for Osteonecrosis.

Osteonecrosis of the hip is the underlying etiology for 3% to 12% of total hip arthroplasties (THAs). Compared with patients who undergo THA because of osteoarthritis, those who do so because of osteo...

Osteonecrosis of the External Auditory Canal Associated With Oral Sorafenib Therapy: Sorafenib and Temporal Bone Osteonecrosis.

To present the first case of osteonecrosis of the external auditory canal associated with sorafenib treatment.

Medial Unicompartmental Knee Arthroplasty for the Treatment of Focal Femoral Osteonecrosis.

Previous research has indicated that unicompartmental arthroplasty may be an effective treatment for focal osteonecrosis in the knee; however, these reports have been composed of small patient cohorts...

Bisphosphonate-associated Osteonecrosis of the Jaws: a Survey of the Level of Knowledge of Dentists about the Risks of Bisphosphonate Therapy.

Bisphosphonate-associated osteonecrosis of the jaws (BAONJ) is a side effect of treatment with bisphosphonate (BP). Reports of this complication have increased recently.

Medical and Biotech [MESH] Definitions

The act of regarding attentively and studying facts and occurrences, gathering data through analyzing, measuring, and drawing conclusions, with the purpose of applying the observed information to theoretical assumptions. Observation as a scientific method in the acquisition of knowledge began in classical antiquity; in modern science and medicine its greatest application is facilitated by modern technology. Observation is one of the components of the research process.

Death of a bone or part of a bone, either atraumatic or posttraumatic.

Necrotic jaws or other maxillofacial skeleton necrosis associated with bisphosphonate use (see BISPHOSPHONATES). Injury, dental procedures, and trauma can trigger the necrotic process.

The study of natural phenomena by observation, measurement, and experimentation.

The observation of successive phases of MOVEMENT by use of a flashing light.

More From BioPortfolio on "The British Osteonecrosis Study"

Quick Search

Relevant Topic

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Searches Linking to this Trial