Alendronate Prevents Bone Loss in Patients with Acute Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled Study

• Published in: The journal of clinical endocrinology and metabolism 2007-04, Vol.92 (4), p.1385-1390
• Main Authors: Gilchrist, N. L., Frampton, C. M., Acland, R. H., Nicholls, M. G., March, R. L., Maguire, P., Heard, A., Reilly, P., Marshall, K.
• Format: Article
• Language: English
• Subjects: Acute Disease; Administration, Oral; Adolescent; Adult; Alendronate - administration & dosage; Alendronate - therapeutic use; Biological and medical sciences; Body Height; Body Mass Index; Bone Density - drug effects; Bone Density Conservation Agents - therapeutic use; Dietary Supplements; Double-Blind Method; Endocrinopathies; Female; Fundamental and applied biological sciences. Psychology; Humans; Male; Medical sciences; Middle Aged; Patient Compliance; Placebos; Spinal Cord Injuries - drug therapy; Spinal Cord Injuries - physiopathology; Treatment Outcome; Vertebrates: endocrinology; Vitamin D - administration & dosage; Walking; Wheelchairs
• ISSN: 0021-972X; 1945-7197
• DOI: 10.1210/jc.2006-2013

Context: Patients who sustain an acute spinal cord injury (SCI) experience rapid dramatic reductions in bone mineral density (BMD), especially marked in sublesional areas and sometimes leading to hypercalcemia and hypercalciuria, as well as increased fracture risk. Objective: In this prospective, double-blind, randomized, placebo-controlled study, we evaluated the hypothesis that oral alendronate administration would preserve BMD when administered soon after acute SCI. Patients and Intervention: Thirty-one patients with acute SCI were randomly allocated to receive oral alendronate 70 mg/wk or placebo, within 10 d of acute SCI, for 12 months. Main Outcome Measurements: At entry and at 3, 6, 12, and 18 months, total body bone density, lumbar and hip BMD, ultrasound of the calcaneus, 24-h urinary calcium, and serum C-telopeptide (βCTX) were measured. Results: At study entry, patients in the two groups were well matched for age, gender, severity of neurological deficit, BMD, urinary calcium, and βCTX. BMD indices declined steadily in the placebo group, and this effect was attenuated significantly by alendronate. After 12 months, there was a 5.3% difference (P < 0.001) in total body BMD and a 17.6% difference (P < 0.001) in the total hip BMD between the two groups. Alendronate compared with placebo induced significant (P < 0.001) reductions in urinary calcium excretion and serum βCTX. No treatment-related side effects were noted. Conclusions: We conclude that alendronate therapy, 70 mg/wk, initiated soon after acute SCI, prevents bone loss and is not associated with side effects.