NCT01656512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

July 30, 2012

Last Update Submit

April 15, 2018

Conditions

Osteoporosis

Keywords

ALLzoledronic acidOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Measure the change in the Bone densitometry due to secondary osteoporosis

    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 Outcomes (1)

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

    week 48 continuation phase

Study Arms (2)

Arm ( A)

ACTIVE COMPARATOR

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

Drug: calcium & vitamin D

Arm (B)

EXPERIMENTAL

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

Drug: zolendronic acid

Interventions

zolendronic acidDRUG

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.

Also known as: bisphosphonates
Arm (B)
calcium & vitamin DDRUG

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

Arm ( A)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous steroid intake more than 72 hours.
  • Less than 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

DiphosphonatesCalciumVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Shimaa Samir, MBBCH

    Children's Cancer Hospital Egypt 57357

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 3, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2014

Study Completion

August 1, 2015

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

EG(1)