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Zometa Study in Pediatric Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified August 2012 by Children's Cancer Hospital Egypt 57357
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier:
NCT01656512
First received: July 30, 2012
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Osteoporosis
 Drug: zolendronic acid
Drug: calcium & vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Cancer Hospital Egypt 57357:

Primary Outcome 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 . ] [ Designated as safety issue: No ]

    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.


Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: bisphosphonates

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656512

Contacts
Contact: Shimaa Samir, MBBCH dr_shaimaasamir@yahoo.com,

Locations
Egypt
Children's Cancer Hospital Egypt 57357 Recruiting
Cairo, Egypt, 11441
Contact: wafaa Rashed, Pharm B     +225351500 ext 7209     waffa.rashed@57357.com    
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
Principal Investigator: Shimaa Samir, MBBCH Children's Cancer Hospital Egypt 57357
  More Information

No publications provided

Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01656512     History of Changes
Other Study ID Numbers: CCHE-ALL002
Study First Received: July 30, 2012
Last Updated: August 1, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Children's Cancer Hospital Egypt 57357:
ALL
zoledronic acid
Osteoporosis

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Osteoporosis
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
 Musculoskeletal Diseases
Calcium, Dietary
Diphosphonates
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013