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)

Phase 3

Terminated

• Conditions: Bone Demineralization Lesions in the Injured Marrow
• Interventions: Drug: NA Cl; Drug: Zoledronic acid

• Registration Number: NCT01802658
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NACL	NA Cl	NACl 100 ml IV. 3 infusions. Administration 3 times over two years.
Zoledronic acid	Zoledronic acid	Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years.

Primary Outcome Measures

Name	Time	Method
determine DMO distal femur at 36 months	october 2015

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Institut Régional de Réadaptation Nancy; 🇫🇷 Nancy, France

Centre Mutualiste Neurologique Propara; 🇫🇷 Montpellier, France

Centre Bouffard - Vercelli CAP Cerbère; 🇫🇷 Cerbère, France

University hospital of Nantes; 🇫🇷 Nantes, France

Centre de l'Arche; 🇫🇷 Saint-Saturnin,, France

CRMPR Les Herbiers; 🇫🇷 Les Herbiers, France

Hôpital R. Poincaré; 🇫🇷 PAris, France

Hôpital Rangueil CHU; 🇫🇷 Toulouse, France

CHU; 🇫🇷 Saint Etienne, France