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Clinical Trials/ACTRN12613000512729
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.

Registry
who.int
Start Date
May 8, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sydney Children's Hospital Network

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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