Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: determine DMO distal femur at 36 months [ Time Frame: october 2015 ]

Original Primary Outcome: Distal femur DMO (g / cm ²) as measured at 36 months [ Time Frame: 04/2016 ]

to determine DMO distal femur at 36 months


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Incidence of fractures of members lower in the first 36 months. [ Time Frame: 04/2016 ]
    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: 04/2016 ]
    To determine the EQ-5D
  • BMD (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36. [ Time Frame: 04/2016 ]
    Determine the BMD
  • Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36 [ Time Frame: 04/2016 ]
    to measure bioassays


Information By: Nantes University Hospital

Dates:
Date Received: February 28, 2013
Date Started: November 2012
Date Completion: August 2020
Last Updated: January 12, 2016
Last Verified: January 2016