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Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Sponsor
Children's Cancer Hospital Egypt 57357 (Other)
Overall Status
Completed
CT.gov ID
NCT01656512
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
46
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: zolendronic acid
  • Drug: calcium & vitamin D
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm ( A)

Arm ( A) : patients will receive calcium & vitamin D

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
Experimental: Arm (B)

we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of

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.
Other Names:
  • bisphosphonates

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure the change in the Bone densitometry due to secondary osteoporosis [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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Cancer Hospital Egypt 57357 Cairo Egypt 11441

    Sponsors and Collaborators

    • Children's Cancer Hospital Egypt 57357

    Investigators

    • Principal Investigator: Shimaa Samir, MBBCH, Children's Cancer Hospital Egypt 57357

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Cancer Hospital Egypt 57357
    ClinicalTrials.gov Identifier:
    NCT01656512
    Other Study ID Numbers:
    • CCHE-ALL002
    First Posted:
    Aug 3, 2012
    Last Update Posted:
    Apr 17, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Children's Cancer Hospital Egypt 57357
    ALL
    zoledronic acid
    Osteoporosis
    Additional relevant MeSH terms:
    Osteoporosis
    Vitamin D
    Diphosphonates
    Calcium

    Study Results

    No Results Posted as of Apr 17, 2018