Status:
TERMINATED
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)
Lead Sponsor:
Nantes University Hospital
Conditions:
Bone Demineralization Lesions in the Injured Marrow
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
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 seconda...
Eligibility Criteria
Inclusion
- 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
- pregnancy.
- osteoporosis.
- cons-indication to Zoledronic Acid.
- drugs affecting bone metabolism
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01802658
Start Date
November 1 2012
End Date
December 1 2016
Last Update
February 28 2018
Active Locations (9)
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1
Centre Bouffard - Vercelli CAP Cerbère
Cervera de la Marenda, France
2
CRMPR Les Herbiers
Les Herbiers, France
3
Centre Mutualiste Neurologique Propara
Montpellier, France
4
Institut Régional de Réadaptation Nancy
Nancy, France