Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Overview

Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents treated for ALL in the Children's Cancer Hospital -Egypt.

Full Title of Study: “Analysis of Outcome of Bisphosphonate Use in Children With ALL- “Case Controlled Study””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2014

Interventions

  • Drug: zolendronic acid
    • patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of Initial dose: (0.025) mg /kg Subsequent doses ( 0.05) mg /kg. Maximum dose of 4 mg.
  • Drug: calcium & vitamin D
    • patients will receive calcium & vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit

Arms, Groups and Cohorts

  • Active Comparator: Arm ( A)
    • Arm ( A) : patients will receive calcium & vitamin D
  • Experimental: Arm (B)
    • we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of

Clinical Trial Outcome Measures

Primary Measures

  • Measure the change in the Bone densitometry due to secondary osteoporosis
    • Time Frame: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
    • we will do the following for evaluation : Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done : At baseline ( not more than 48 hours of start of therapy with steroids) At week 48 At end of treatment ( week 120 for girls ) & ( week 146 for boys) As required clinically eg: fractures . Magnetic resonance imaging of both hips & knees will be done at reinduction I & II & if symptomatic.

Secondary Measures

  • – To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.
    • Time Frame: week 48 continuation phase

Participating in This Clinical Trial

Inclusion Criteria

  • Age above 5 & below 18 years at the time of diagnosis. – Newly diagnosed ALL patients. – Not previously treated, previous steroid intake not more than 72 hours. – Treated according to St Judy study XV protocol. Exclusion Criteria:

  • Previous steroid intake more than 72 hours. – Less than 5 years

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Cancer Hospital Egypt 57357
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shimaa Samir, MBBCH, Principal Investigator, Children’s Cancer Hospital Egypt 57357

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