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)

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 3

Conditions: Bone Demineralization Lesions in the Injured Marrow

Treatments: Drug: NA Cl; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01802658

2012-001778-27 (EudraCT Number)

BRD/11/06-P

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

Zoledronic acid

Active Comparator group

Description:

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

Treatment:

Drug: Zoledronic acid

NACL

Placebo Comparator group

Description:

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

Treatment:

Drug: NA Cl