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Zometa Study in Pediatric Acute Lymphoblastic Leukemia

NCT01656512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    lead OTHER

Principal Investigators

  • Shimaa Samir, MBBCH · Children's Cancer Hospital Egypt 57357

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-01-31
Completion
2015-08-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656512 on ClinicalTrials.gov