Clinical trial NCT01802658: 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)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bone Demineralization Lesions in the Injured Marrow
Keywords: Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: determine DMO distal femur at 36 months
timeFrame: october 2015
Secondary outcomes:
measure: Incidence of fractures of members lower in the first 36 months.
timeFrame: october 2015
measure: Response to the EQ-5D questionnaire at baseline, M12, M24, M36.
timeFrame: october 2015
measure: DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.
timeFrame: october 2015
measure: Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36
timeFrame: october 2015
Other outcomes:
measure: Further study of biological markers of bone resorption
timeFrame: october 2015
measure: Study of bone architecture by QCT p
timeFrame: october 2015
measure: Establishment of a bio-collection.
timeFrame: october 2015
measure: Additional clinical follow-up study.
timeFrame: october 2015
measure: Medico-economic analysis.
timeFrame: october 2015
Locations:
city: Cerbère
country: France
facility: Centre Bouffard - Vercelli CAP Cerbère
city: Les Herbiers
country: France
facility: CRMPR Les Herbiers
city: Montpellier
country: France
facility: Centre Mutualiste Neurologique Propara
city: Nancy
country: France
facility: Institut Régional de Réadaptation Nancy
city: Nantes
country: France
facility: University hospital of Nantes
city: PAris
country: France
facility: Hôpital R. Poincaré
city: Saint Etienne
country: France
facility: CHU
city: Saint-Saturnin,
country: France
facility: Centre de l'Arche
city: Toulouse
country: France
facility: Hôpital Rangueil CHU
Study officials:
References: