Preventive treatment with alendronate for osteoporosis in people with spinal cord injuries

• 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.; MedDRA version: 14.1Level: HLGTClassification code 10041543Term: Spinal cord and nerve root disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-000321-41-ES
• Lead Sponsor: FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 23 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified