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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Bone Demineralization Lesions in the Injured Marrow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zoledronic acid

Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years.

Group Type ACTIVE_COMPARATOR

Zoledronic acid

Intervention Type DRUG

Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.

NACL

NACl 100 ml IV. 3 infusions. Administration 3 times over two years.

Group Type PLACEBO_COMPARATOR

NA Cl

Intervention Type DRUG

NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.

Interventions

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Zoledronic acid

Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.

Intervention Type DRUG

NA Cl

NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.

Intervention Type DRUG

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