Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)

Study Overview
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Brief Summary
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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.

Official Title
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Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled

Conditions
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Bone Demineralization Lesions in the Injured Marrow

Intervention / Treatment
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* Drug: Zoledronic acid
* Drug: NA Cl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable, level of injury C5 L2, AIS grade A to D. Female or male between 18 and 45 years. No pregnancy. No osteoporosis. Good oral health. Good glomerular filtration. No cons-indication to Zoledronic Acid. No drugs affecting bone metabolism Exclusion Criteria: pregnancy. osteoporosis. cons-indication to Zoledronic Acid. drugs affecting bone metabolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zoledronic acid<br>Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years. | Drug: Zoledronic acid<br>* Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.<br>|
| Placebo Comparator: NACL<br>NACl 100 ml IV. 3 infusions. Administration 3 times over two years. | Drug: NA Cl<br>* NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine DMO distal femur at 36 months |  | october 2015 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid