RecruitingPhase 1ACTRN12613000512729

A study to evaluate safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents.

A pilot study to evaluate safety and feasibility of administrating prophylactic doses of zoledronic acid to prevent symptomatic osteonecrosis following chemotherapy for acute lymphoblastic leukemia and lymphoma in children and adolescents.


Sponsor

Sydney Children's Hospital Network

Enrollment

10 participants

Start Date

Oct 11, 2012

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a bone-protecting drug called zoledronic acid can prevent osteonecrosis — a painful condition where bone tissue dies near joints — in children and teenagers being treated for acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma. Chemotherapy can sometimes damage bone tissue, especially in larger joints. Children over 10 will receive zoledronic acid as an IV infusion twice during chemotherapy, while those aged 5–10 will be observed closely without the drug. All participants will be monitored with blood tests and imaging for up to 2 years. You may be eligible if: - Your child is between 5 and 16 years old - Your child has been diagnosed with acute lymphoblastic leukaemia or lymphoblastic lymphoma - Children aged 5–10 must be able to have an MRI scan without general anaesthesia You may NOT be eligible if: - Your child has very low vitamin D levels (25-hydroxy vitamin D below 50 nmol/L) - Your child has low blood calcium - Your child has previously used bisphosphonate medications - Your child has severely reduced kidney function (GFR below 35 ml/min) - Your child has active uveitis (eye inflammation) - Your child has a primary bone disease such as osteogenesis imperfecta - Your child requires general anaesthesia for MRI Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 lymph

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.


Locations(1)

The Children's Hospital at Westmead - Westmead

NSW, Australia

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ACTRN12613000512729


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