RecruitingPhase 3ACTRN12618000915257

Preventing Osteoporosis in Patients with Spinal Cord Injury (SCI)

A Prospective Study Aimed at Preventing Osteoporosis in Patients Following an Acute Traumatic Spinal Cord Injury (ASCI) Using Early Intervention with a Potent Anti-Resorptive Therapy, Zoledronic Acid.

Sponsor

Northern Sydney Local Health District - Royal North Shore Hospital

Enrollment

100 participants

Start Date

Oct 18, 2018

Study Type

Interventional

Conditions

Spinal Cord Injury (SCI)Osteoporosis

Summary

Osteoporosis is a major cause of morbidity in patients with spinal cord injury (SCI) and is under-recognised in this population. Osteoporosis is universal in SCI sufferers and typically results in pelvic and lower limb fractures which heighten the risk of limb contracture, pressure sores, local bone complications including infection and non-union and thus, increases complication and death rates in this population. The primary aim and objective of this prospective study is to try and prevent the occurrence of osteoporosis in acute SCI. This aim involves early assessment of musculoskeletal parameters in SCI patients within 8-12 weeks following an acute traumatic spinal cord injury, and the use of a preventative treatment with an already approved osteoporosis drug to prevent the rapid bone loss which occurs in the acute phase of the spinal cord injury.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a spinal cord injury, bones — particularly in the pelvis and legs — rapidly lose density in the weeks and months that follow. This happens because the muscles that normally stress and stimulate bone through movement are no longer active. The resulting osteoporosis can lead to fractures from minor bumps or falls, which in turn cause serious complications and can even be life-threatening. This study aims to prevent this bone loss by treating patients early — within 8 to 12 weeks of an acute traumatic spinal cord injury — with zoledronic acid, a medication that is already approved and widely used to treat osteoporosis in other settings. Researchers hope that starting treatment early enough can preserve bone density and reduce the risk of fractures down the track. You may be eligible if you are 18 or older and have recently experienced a traumatic spinal cord injury. People with non-traumatic causes of spinal cord injury (such as tumours or degenerative disease), known sensitivity to zoledronic acid, pregnancy, or active malignancy in the past five years are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

A single dose of intravenous infusion of 4mg zoledronic acid will be administered by the research nurse, as soon as the participant's serum vitamin D levels are confirmed to be replete, following an

A single dose of intravenous infusion of 4mg zoledronic acid will be administered by the research nurse, as soon as the participant's serum vitamin D levels are confirmed to be replete, following an acute spinal cord injury.(ASCI). Baseline pathology tests for musculoskeletal assessment will be performed, with follow. up tests at Month 6, Month 12 and yearly for 5 years. DXA measurements for bone density and body composition will be performed within 6 weeks following the ASCI and yearly for 5 years. Review in the Metabolic Clinic within 6 weeks of injury, at Month 6, Month 12 and yearly for 5 years.