Effect of early treatment with zoledronic acid on prevention of bone loss in spinal cord injury patients a randomized prospective interventional study

Abstract

This hospital based randomized, prospective, longitudinal study was conducted at Rehabilitation Research and State Spinal Injury Centre, by department of Physical and Rehabilitation Medicine (PRM) Jaipur, India to assess the magnitude of bone loss and to study the effect of early administration of zoledronic acid in the prevention of bone loss following spinal cord injury. Subjects were randomized to either control group to receive standard nursing and medical treatment along with physical therapy for traumatic spinal cord injury or intervention group to receive standard treatment along with intravenous zoledronic acid (5 mg/100 mL) infusion. A total of 212 acute spinal cord injury (SCI) patients were screened for eligibility criteria and 118 eligible patients were assigned to either control or intervention group. In total, 28 patients in control group and 29 patients in the intervention group completed the study. Bone mineral density (BMD) was measured at hip and forearm at baseline, 3 months, 6 months and 12 months by Hologic QDR-Delphi dual X-ray absorptiometry (DXA) machine. After comparison of the BMD by DXA scan at baseline, 3, 6 & 12 months a significant difference ( P < 0.03) was observed between control and interventional group at both 6 and 12 months in both quadriplegics and paraplegics at all sites of hip and at 12 months in quadriplegics at all sites of forearm. This was a pioneer study of this nature in India which showed a single dose of 5 mg intravenous zoledronic acid to be an effective treatment in preventing bone loss at the hip and forearm for 12 months following SCI. However, in the bones which continue to be non-weight-bearing, it is logical that there will be ongoing bone resorption. So, larger, controlled studies with longer durations of follow up are still required to determine whether further treatment with bisphosphonates would be required.