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) (DBMZol)
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.
|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.||Drug: Zoledronic acid Drug: NA Cl||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled|
- determine DMO distal femur at 36 months [ Time Frame: october 2015 ]
- Incidence of fractures of members lower in the first 36 months. [ Time Frame: october 2015 ]to determine incidence of fractures of members lower in the first 36 months
- Response to the EQ-5D questionnaire at baseline, M12, M24, M36. [ Time Frame: october 2015 ]To determine the EQ-5D
- DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36. [ Time Frame: october 2015 ]Determine the DMO
- Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36 [ Time Frame: october 2015 ]to measure bioassays
- Further study of biological markers of bone resorption [ Time Frame: october 2015 ]
- Study of bone architecture by QCT p [ Time Frame: october 2015 ]
- Establishment of a bio-collection. [ Time Frame: october 2015 ]
- Additional clinical follow-up study. [ Time Frame: october 2015 ]
- Medico-economic analysis. [ Time Frame: october 2015 ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||August 2020 (Final data collection date for primary outcome measure)|
Active Comparator: Zoledronic acid
Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years.
Drug: Zoledronic acid
Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.
Placebo Comparator: NACL
NACl 100 ml IV. 3 infusions. Administration 3 times over two years.
Drug: NA Cl
NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802658
|Contact: Brigitte Perrouin - verbe, MD||02 40 84 60 firstname.lastname@example.org|
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