Zometa Study in Pediatric Acute Lymphoblastic Leukemia

April 15, 2018 updated by: Children's Cancer Hospital Egypt 57357

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11441
        • Children's Cancer Hospital Egypt 57357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

  1. Initial dose: (0.025) mg /kg
  2. Subsequent doses ( 0.05) mg /kg.
  3. Maximum dose of 4 mg.
Other Names:
  • bisphosphonates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 :

  1. 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 .
  2. Magnetic resonance imaging of both hips & knees will be done at reinduction I & II & if symptomatic.
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 .

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Hospital Egypt 57357

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHE-ALL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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