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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with osteoporosis associated to multiple disabilities | Treated with zoledronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | Treatment of osteoporosis |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Baseline | |
| Sex | Baseline | |
| Height | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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All children followed for osteoporosis associated to multiple disabilities, treated with zoledronic acid, followed at pediatric department of Nancy hospital, between 01/01/2012 and 11/01/2016.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital - CHRU de Nancy | Vandœuvre-lès-Nancy | France |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |