Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm ( A)

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

Group Type ACTIVE_COMPARATOR

calcium & vitamin D

Intervention Type DRUG

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 (B)

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

Group Type EXPERIMENTAL

zolendronic acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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bisphosphonates

Eligibility Criteria

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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.