Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

Study Overview
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Brief Summary
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The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities. Secondary purposes are: Description of child population with osteoporosis in the context of motor impairment in Lorraine region Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities Description of current osteoporosis preventive care Description of risk factors associated to bone status (drugs) Evaluation of zoledronic acid treatment on fracture numbers Evaluation of zoledronic acid on phosphocalcic profile Description of side effects of zoledronic acid in this indication Description of treatment effects in the sub-population of children with Rett syndrome.

Official Title
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Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities

Conditions
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Multiple Disability, Osteoporosis

Intervention / Treatment
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* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non refusal of parents of participation of their child to the study Patients followed for multiple disabilities Osteoporosis: lumbar osteodensitometry z-score <-2.5 SD associated or not to pathologic fracture Exclusion Criteria: Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta) Absence of multiple disabilities

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with osteoporosis associated to multiple disabilities<br>Treated with zoledronic acid | Drug: Zoledronic Acid<br>* Treatment of osteoporosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (before start of zoledronic acid treatment) lumbar bone density | reported in Z-score | through study completion, 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age |  | Baseline | 
| Sex |  | Baseline | 
| Height |  | Baseline | 
| Weight |  | Baseline | 
| Occurrence of bone fractures |  | Until baseline | 
| Long-term administration of vitamin/calcium supplement or not |  | baseline | 
| Administration of drugs or not |  | baseline | 
| Number of fractures after the start of zoledronic acid treatment |  | through study completion, 4 years | 
| Change from baseline phosphocalcic profile evaluation |  | through study completion, 4 years | 
| Frequency of side effects |  | through study completion, 4 years | 
| Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment |  | 1 year from baseline |