Osteoporosis
Conditions
Keywords
ALL, zoledronic acid, Osteoporosis
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.
Interventions
DRUGzolendronic 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.
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
Children's Cancer Hospital Egypt 57357
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the change in the Bone densitometry due to secondary osteoporosis | 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 . | 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. |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms. | week 48 continuation phase |
Countries
Egypt
Outcome results
None listed