ACTRN12613000512729
Recruiting
Phase 1
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.
Sydney Children's Hospital Network0 sites10 target enrollmentMay 8, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute lymphoblastic leukemia
- Sponsor
- Sydney Children's Hospital Network
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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