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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01802658
First received: February 28, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
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.
Drug: Zoledronic acid
Drug: NA Cl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • determine DMO distal femur at 36 months [ Time Frame: october 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of fractures of members lower in the first 36 months. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
    to determine incidence of fractures of members lower in the first 36 months

  • Response to the EQ-5D questionnaire at baseline, M12, M24, M36. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
    To determine the EQ-5D

  • DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
    Determine the DMO

  • Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36 [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
    to measure bioassays


Other Outcome Measures:
  • Further study of biological markers of bone resorption [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
  • Study of bone architecture by QCT p [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
  • Establishment of a bio-collection. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
  • Additional clinical follow-up study. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]
  • Medico-economic analysis. [ Time Frame: october 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802658

Contacts
Contact: Brigitte Perrouin - verbe, MD 02 40 84 60 47 brigitte.perrouinverbe@chu-nantes.fr

Locations
France
Centre Bouffard - Vercelli CAP Cerbère Not yet recruiting
Cerbère, France
Contact: Enjalbert    04 68 88 74 06    michel.enjalbert@wanadoo.fr   
CRMPR Les Herbiers Not yet recruiting
Les Herbiers, France
Contact: BEURET-BLANQUART    02 35 59 52 14      
Centre Mutualiste Neurologique Propara Not yet recruiting
Montpellier, France
Contact: FATTAL    0467046704    c.fattal@propara.languedoc-mutualite.fr   
Institut Régional de Réadaptation Nancy Not yet recruiting
Nancy, France
Contact: BEIS    03 83 22 22 31    jeanmarie.beis@irr.u-nancy.frr   
University hospital of Nantes Recruiting
Nantes, France, 44000
Contact: Perrouin - Verbe    02 40 84 60 47    brigitte.perrouinverbe@chu-nantes.fr   
Hôpital R. Poincaré Not yet recruiting
PAris, France
Contact: BENSMAIL    01 47 10 70 60    djamel.bensmail@rpc.aphp.fr   
CHU Not yet recruiting
Saint Etienne, France
Contact: GIRAUX    04 77 12 77 56    pascal.giraux@univ-st-etienne.fr   
Centre de l'Arche Not yet recruiting
Saint-Saturnin,, France
Contact: EGON    02.43.51.72.86    guyegon@hotmail.com   
Hôpital Rangueil CHU Not yet recruiting
Toulouse, France
Contact: CASTEL-LACANAL    05 61 32 39 27    castel-lacanal.e@chu-toulouse.fr   
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01802658     History of Changes
Other Study ID Numbers: 11/06-P, 2012-001778-27
Study First Received: February 28, 2013
Last Updated: September 5, 2013
Health Authority: France: AFSSAPS - French Heaalth Products Safety Agency

Keywords provided by Nantes University Hospital:
Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid

Additional relevant MeSH terms:
Osteoporosis
Spinal Cord Injuries
Bone Demineralization, Pathologic
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014