ACTRN12618000915257RecruitingPhase 3

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.

orthern Sydney Local Health District - Royal North Shore Hospital0 sites100 target enrollmentStarted: May 30, 2018Last updated: October 26, 2021

Conditions

Trial Snapshot

No summary available.

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

•1. Subjects with a non-traumatic spinal cord injury (eg tumours, degenerative diseases of the spinal column, vascular and autoimmune disorders)
•2. 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.
•3. Malignancy within the past 5 years, except for non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
•4. Subjects with a known sensitivity to any of the drugs to be administered (zoledronic acid, vitamin D if required).
•5. 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
•6. 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
•7. Female subjects who, at the time of injury, are pregnant.

Sponsor

orthern Sydney Local Health District - Royal North Shore Hospital