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)

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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802658

Acronym

DBMZol

Enrollment

Registered

2013-03-01

Start date

2012-11-30

Completion date

2016-12-31

Last updated

2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Demineralization Lesions in the Injured Marrow

Keywords

Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid

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.

Interventions

DRUGZoledronic acid

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

DRUGNA Cl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
determine DMO distal femur at 36 months	october 2015

Secondary

Measure	Time frame	Description
Incidence of fractures of members lower in the first 36 months.	october 2015	to determine incidence of fractures of members lower in the first 36 months
Response to the EQ-5D questionnaire at baseline, M12, M24, M36.	october 2015	To determine the EQ-5D
DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.	october 2015	Determine the DMO
Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36	october 2015	to measure bioassays

Other

Measure	Time frame
Further study of biological markers of bone resorption	october 2015
Study of bone architecture by QCT p	october 2015
Establishment of a bio-collection.	october 2015
Additional clinical follow-up study.	october 2015
Medico-economic analysis.	october 2015

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026