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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)

NCT01802658 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-02-28

No results posted yet for this study

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.

Conditions

  • Bone Demineralization Lesions in the Injured Marrow

Interventions

DRUG

Zoledronic acid

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

DRUG

NA Cl

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802658 on ClinicalTrials.gov