Bone Demineralization Lesions in the Injured Marrow Clinical Trial
— DBMZolOfficial 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
| Verified date | February 2018 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Bouffard - Vercelli CAP Cerbère | Cerbère | |
| France | CRMPR Les Herbiers | Les Herbiers | |
| France | Centre Mutualiste Neurologique Propara | Montpellier | |
| France | Institut Régional de Réadaptation Nancy | Nancy | |
| France | University hospital of Nantes | Nantes | |
| France | Hôpital R. Poincaré | PAris | |
| France | CHU | Saint Etienne | |
| France | Centre de l'Arche | Saint-Saturnin, | |
| France | Hôpital Rangueil CHU | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Further study of biological markers of bone resorption | october 2015 | ||
| Other | Study of bone architecture by QCT p | october 2015 | ||
| Other | Establishment of a bio-collection. | october 2015 | ||
| Other | Additional clinical follow-up study. | october 2015 | ||
| Other | Medico-economic analysis. | october 2015 | ||
| Primary | determine DMO distal femur at 36 months | october 2015 | ||
| Secondary | Incidence of fractures of members lower in the first 36 months. | to determine incidence of fractures of members lower in the first 36 months | october 2015 | |
| Secondary | Response to the EQ-5D questionnaire at baseline, M12, M24, M36. | To determine the EQ-5D | october 2015 | |
| Secondary | DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36. | Determine the DMO | october 2015 | |
| Secondary | Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36 | to measure bioassays | october 2015 |