Back to results

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

zolendronic acid

calcium & vitamin D

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring ALL, zoledronic acid, Osteoporosis

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm ( A)

Arm (B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Measure the change in the Bone densitometry due to secondary osteoporosis

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

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

Full Information

NCT ID

NCT01656512

First Posted

July 30, 2012

Last Updated

April 15, 2018

Sponsor

Children's Cancer Hospital Egypt 57357

1. Study Identification

Unique Protocol Identification Number

NCT01656512

Brief Title

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Cancer Hospital Egypt 57357

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

ALL, zoledronic acid, Osteoporosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm ( A)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm (B)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

zolendronic acid

Other Intervention Name(s)

bisphosphonates

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

calcium & vitamin D

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure the change in the Bone densitometry due to secondary osteoporosis

Description

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 .

Secondary Outcome Measure Information:

Title

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

Time Frame

week 48 continuation phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shimaa Samir, MBBCH

Organizational Affiliation

Children's Cancer Hospital Egypt 57357

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Cancer Hospital Egypt 57357

City

Cairo

ZIP/Postal Code

11441

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

We'll reach out to this number within 24 hrs