None listed
Conditions
Brief summary
The study is evaluating the safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents. Who is it for? You or your child may be eligible to join this study if you/they are aged between 5 and 16 years and have been diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. Trial details: In participants more than 10 years of age the drug zoledronic acid will be intravenously infused (i.e. administered directly into the vein) on day 8 of chemotherapy and again 6 weeks later (Group 1). Children between 5-10 years of age will not receive zoledronic acid (Group 2). Both groups will be regularly monitored by blood tests and radiological interventions for up to 2 years post treatment in order to determine the feasibility and safety of zoledronic acid and the incidence of osteonecrosis (joint complication of cancer treatment).
Interventions
Group 1 :2 doses of Zoledronic acid (0.025mg/kg/dose ,Intravenous infusion) will be administered to children more than 10 years of age at diagnosis of Acute lymphoblastic leukemia /lymphoblastic lymphoma. First dose will be administered on Day 8 of chemotherapy and second dose will be administered 6 weeks after that.Serial blood tests and radiological interventions will be carried out according to the protocol.
Group 2 : Includes children between 5-10 years of age.They do not get Zoledronic acid
Group 1 :2 doses of Zoledronic acid (0.025mg/kg/dose ,Intravenous infusion) will be administered to children more than 10 years of age at diagnosis of Acute lymphoblastic leukemia /lymphoblastic lymphoma. First dose will be administered on Day 8 of chemotherapy and second dose will be administered 6 weeks after that.Serial blood tests and radiological interventions will be carried out according to the protocol. Group 2 : Includes children between 5-10 years of age.They do not get Zoledronic acid.Blood tests and radiological intervention will be carried out according to the prtocol.This is done to determine baseline incidence of osteonecrosis in this population.
Sponsors
Sydney Children's Hospital Network
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1) Diagnosis of Acute lymphoblastic leukemia or lymphoblastic lymphoma 2) Age more than 10 years for Zoledronic acid intervention(group1) 3) Age between 5yr-10 yr and able to have MRI without general anaesthetic for investigations (group2)
Exclusion criteria
1) 25 hydroxy vitamin D< 50 nmol/L 2) Hypocalcemia corrected for albumin 3) Prior bisphosphonate use 4) Estimated glomerular filtration rate (GFR) <35ml/min/1.73 m2 at screening based on Schwartz formula 5) Diagnosis of active uveitis 6) History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile osteoporosis, rickets/osteomalacia) 7) Unable to have MRI without general anaesthesia
Outcome results
None listed