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: 14.1 Level: HLGT Classification code 10041543 Term: Spinal cord and nerve root disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AC ALENDRONICO SEMANAL 70MG
Product Name: AC ALENDRONICO KERN PHARMA 70MG
Product Code: 656456
Pharmaceutical Form: Tablet
INN or Proposed INN: ALENDRONATE SODIUM
CAS Number: 121268-17-5
C
Sponsors
FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓN
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Knowing the effectiveness in preventing bone loss in the population studied, treatment with calcifediol (to maintain serum 25 (OH) vitamin D = 30 ng / ml) plus calcium-rich diet (1200 mg / day) and alendronatato, with respect to treatment with calcifediol (to maintain serum 25 (OH) vitamin D = 30 ng / ml) plus calcium-rich diet (1200 mg / day). We understand effectiveness of bone mass difference between the two groups, measured by DEXA in the lower limbs ("total body legs") of 4% or higher for the group receiving alendronate.;Secondary Objective: To determine the safety of treatment (incidence of moderate to severe hypercalcemia, incidence of moderate-severe hypercalciuria, hyperphosphatemia incidence of moderate to severe incidence of calcium urolithiasis, ectopic calcification incidence). Find a pattern of action in preventing bone loss in the study population. Describe the evolution of bone turnover markers (ß-CTX, bone alkaline phosphatase, osteocalcin and intact P1NP) in serum in the two treatment groups;Primary end point(s): Difference between groups in the percentage reduction in bone mineral density with respect to the time of injury, after 12 months of treatment. The bone density was measured by densitometry of dual-energy radiograph absorptiometry (DEXA) in anterior lumbar spine, both hips and full body, team Hologic Explorer / W';Timepoint(s) of evaluation of this end point: The year of treatment with alendronate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In blood, total calcium, albumin-corrected calcium, ionized calcium, phosphorus, magnesium, total alkaline phosphatase, 25OH vitamin D, 1.25 (OH) 2 vitamin D, PTH, ß-CTX, bone alkaline phosphatase, osteocalcin and P1NP intact . In 24-hour urine calcium, phosphorus, magnesium and creatinine clearance. In isolated voiding urine: calcium / creatinine ratio.;Timepoint(s) of evaluation of this end point: Once a month | — |
Countries
Spain
Contacts
Public ContactOficina de información de EC
FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓN (FUHNPAIIN)
Outcome results
None listed