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 个研究点开始时间: 2012年3月5日最近更新: 2012年5月23日

适应症

试验速览

暂无简介。

•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

•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.

发起方

FUNDACION HOSPITAL NACIONAL DE PARAPLEJICOS PARA LA INVESTIGACIÓN Y LA INTEGRACIÓ