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

Inclusion Criteria2

Adults aged 18 years and older who have sustained an acute traumatic spinal cord injury.
Subject has provided an informed consent.

Exclusion Criteria7

Subjects with a non-traumatic spinal cord injury (eg tumours, degenerative diseases of the spinal column, vascular and autoimmune disorders)
Subject is currently involved in another investigational device or drug study, or <30 days since ending another investigational device of drug study or receiving an investigational agent.
Malignancy within the past 5 years, except for non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
Subjects with a known sensitivity to any of the drugs to be administered (zoledronic acid, vitamin D if required).
Subject is known to have any condition or illness (acute, chronic or history) which, in the opinion of the investigator, might interfere with the evaluation of the study treatment or may otherwise compromise the safety of the patient
Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give informed consent and/or to comply with all the required study procedures
Female subjects who, at the time of injury, are pregnant.

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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.