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) (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

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.

Study Overview

• Status: Terminated
• Conditions: Bone Demineralization Lesions in the Injured Marrow
• Intervention / Treatment: Drug: Zoledronic acid; Drug: NA Cl

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Cerbère, France
    • Centre Bouffard - Vercelli CAP Cerbère
  • Les Herbiers, France
    • CRMPR Les Herbiers
  • Montpellier, France
    • Centre Mutualiste Neurologique Propara
  • Nancy, France
    • Institut Régional de Réadaptation Nancy
  • Nantes, France, 44000
    • University Hospital of Nantes
  • PAris, France
    • Hôpital R. Poincaré
  • Saint Etienne, France
    • CHU
  • Saint-Saturnin,, France
    • Centre de l'Arche
  • Toulouse, France
    • Hôpital Rangueil CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zoledronic acid; Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years.	Drug: Zoledronic acid; Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.
Placebo Comparator: NACL; NACl 100 ml IV. 3 infusions. Administration 3 times over two years.	Drug: NA Cl; NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
determine DMO distal femur at 36 months	october 2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Response to the EQ-5D questionnaire at baseline, M12, M24, M36.	To determine the EQ-5D	october 2015
DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.	Determine the DMO	october 2015
Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36	to measure bioassays	october 2015

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Bone Demineralization, Pathologic; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: BRD/11/06-P; 2012-001778-27 (EudraCT Number)