Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Children's Cancer Hospital Egypt 57357

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: calcium & vitamin D; Drug: zolendronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01656512

CCHE-ALL002

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Arm ( A)

Active Comparator group

Description:

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

Treatment:

Drug: calcium & vitamin D

Arm (B)

Experimental group

Description:

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

Treatment:

Drug: zolendronic acid