Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01802658
Status:
TERMINATED
Last Update Posted:
2018-02-28
First Post:
2013-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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 (DBMZol)
Sponsor:
Nantes University Hospital
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruiting Difficulty
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBMZol
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001778-27 | EUDRACT_NUMBER | None | View |