BONES: The British Osteonecrosis Study.
Research type
Research Study
Full title
BONES: 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 or lymphoblastic lymphoma.
IRAS ID
185365
Contact name
Nadia L Amin
Contact email
Sponsor organisation
Unviersity of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 5 months, 31 days
Research summary
As treatment for leukaemia has improved, we now expect to cure most children, teenagers and young adults who present with acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LL). Consequently there is an increased focus on improving quality of life during and after treatment without compromising cure. Osteonecrosis is one of the most debilitating complications, and is likely to occur as a consequence of the treatment given to patients. The patients at greatest risk of developing symptomatic osteonecrosis are the older children, teenage and young adult population, and this is the group the study focusses on. We aim to understand the incidence, risk factors and natural history of osteonecrosis in these patients with ALL and LL.
This study will involve serial magnetic resonance imaging of lower limbs, markers of bone turnover and physiotherapy assessments of patients with ALL OR LL aged between 10 and 25 years. Investigations will occur within two weeks of diagnosis, at the end of delayed intensification and one, two and three years after the start of maintenance therapy. There will also be analysis of routine clinical imaging and investigations. The results should help us to identify early changes signifying potential development of symptomatic osteonecrosis, and lead to improved risk stratification of patients.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0206
Date of REC Opinion
12 Jul 2016
REC opinion
Further Information Favourable Opinion