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Clinical Trials/EUCTR2012-000321-41-ES
EUCTR2012-000321-41-ES
Active, not recruiting
Not Applicable

PREVENTIVE TREATMENT OF BONE MASS LOSS WITH ALENDRONATE AND CALCIFEDIOL IN PATIENTS WITH ACUTE SPINAL CORD INJURY

FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓ0 sitesMarch 5, 2012
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ConditionsPreventing loss of bone density in patients with spinal cord injury of traumatic etiology complete during the first year of evolution of the lesion.MedDRA version: 14.1Level: HLGTClassification code 10041543Term: Spinal cord and nerve root disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
DrugsAC ALENDRONICO SEMANAL 70MG

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preventing loss of bone density in patients with spinal cord injury of traumatic etiology complete during the first year of evolution of the lesion.
Sponsor
FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓ
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓ

Eligibility Criteria

Inclusion Criteria

  • •Patients with spinal cord injury (SCI) of traumatic etiology of 8 or fewer weeks of evolution, men and women between 18 and 50 years of age, motor complete injuries, ie ASIA A and B grade, level of spinal injury cord, from C4 to L1\.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 66
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Hypercalcemia (corrected Ca \= 12 mg / dl and / or Ca ion \= 5\.54 mg / dl) prior to the LME menopause, previous treatment with bisphosphonates, patients who are pregnant or nursing, chronic renal insufficiency (CrCl \<60 ml / min ), primary hyperparathyroidism, hyperthyroidism longstanding untreated, kidney stones and / or urological surgery, treatment with lithium, thiazides, esophagitis, carcinoma of the esophagus. Other risk factors for fracture: Type 1 diabetes, rheumatoid arthritis, chronic treatment with corticosteroids, osteogenesis imperfecta, malabsorption, chronic malnutrition and chronic liver disease. Unable to maintain sitting position for at least half an hour. Failure to obtain informed consent.

Outcomes

Primary Outcomes

Not specified

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