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NCT Number: NCT01656512

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolendronic acid

Drug

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.

Other names: bisphosphonates

calcium & vitamin D

Drug

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

Primary outcomes

  1. 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 outcomes

  1. - To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.

    Time frame: week 48 continuation phase

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Aug 3, 2012
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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