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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001778-27 | EudraCT Number |
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Recruiting Difficulty
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Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.
Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.
No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid | Active Comparator | Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years. |
|
| NACL | Placebo Comparator | NACl 100 ml IV. 3 infusions. Administration 3 times over two years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| determine DMO distal femur at 36 months | october 2015 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of fractures of members lower in the first 36 months. | to determine incidence of fractures of members lower in the first 36 months | october 2015 |
| Response to the EQ-5D questionnaire at baseline, M12, M24, M36. |
| Measure | Description | Time Frame |
|---|---|---|
| Further study of biological markers of bone resorption | october 2015 | |
| Study of bone architecture by QCT p | october 2015 | |
| Establishment of a bio-collection. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Bouffard - Vercelli CAP Cerbère | Cervera de la Marenda | France | ||||
| CRMPR Les Herbiers |
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| NA Cl | Drug | NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years. |
|
To determine the EQ-5D
| october 2015 |
| DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36. | Determine the DMO | october 2015 |
| Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36 | to measure bioassays | october 2015 |
| october 2015 |
| Additional clinical follow-up study. | october 2015 |
| Medico-economic analysis. | october 2015 |
| Les Herbiers |
| France |
| Centre Mutualiste Neurologique Propara | Montpellier | France |
| Institut Régional de Réadaptation Nancy | Nancy | France |
| University hospital of Nantes | Nantes | 44000 | France |
| Hôpital R. Poincaré | Paris | France |
| CHU | Saint-Etienne | France |
| Centre de l'Arche | Saint-Saturnin | France |
| Hôpital Rangueil CHU | Toulouse | France |
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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