Zometa Study in Pediatric Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Children's Cancer Hospital Egypt 57357.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014