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.
Phase 1
Recruiting
- Conditions
- Acute lymphoblastic leukemiaOsteonecrosisCancer - Leukaemia - Acute leukaemiaMusculoskeletal - Other muscular and skeletal disordersLymphoblastic lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
- Registration Number
- ACTRN12613000512729
- Lead Sponsor
- Sydney Children's Hospital Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine safety and feasibility of administering 2 doses of Intravenous Zoledronic acid to children, more than 10 years of age at diagnosis, with acute lymphoblastic leukemia and lymphoblastic lymphoma for prevention of symptomatic chemotherapy related osteonecrosis.<br>Blood tests and radiological investigations will be done at given time intervals.[Baseline<br>24 hours,48 hours,72hours after both interventions<br>At 4 months 1 year and 2 years after second dose of Zoledronic acid.]
- Secondary Outcome Measures
Name Time Method