RecruitingPhase 4ACTRN12623000141640

Investigating the effect of Romosozumab on osteoporosis following spinal cord injury

Sponsor

Princess Alexandra Hospital, Metro South Health

Enrollment

32 participants

Start Date

Dec 19, 2024

Study Type

Interventional

Conditions

Osteoporosis Acute Spinal Cord Injury

Summary

Spinal cord injury (SCI) is associated with severe rapid bone loss below the level of injury, and subsequently osteoporosis and increased risk of minimal trauma fractures. There is currently no effective treatment for treating SCI-induced osteoporosis. Current methods of prevention, predominantly bisphosphonates, have very limited efficacy. Sclerostin is now known to mediate SCI-induced bone loss. Recently, a sclerostin inhibitor, romosozumab, has become available for the treatment of osteoporosis. Sclerostin inhibition prevents bone loss following SCI in pre-clinical studies. We hypothesis that romosozumab will be highly effective for the prevention of bone loss and osteoporosis in SCI. This study will compare romosozumab followed by the bisphosphonate, zoledronic acid versus zoledronic acid alone, administered early after acute SCI, for prevention of SCI-induced osteoporosis. We will recruit 32 participants (16 in each group) in a randomised controlled study. Participants will either receive romosozumab for 12 months followed by maintenance therapy with zoledronic acid, or zoledronic acid alone. We expect to show that the marked bone loss which occurs following acute SCI can be prevented by the administration of romosozumab.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Spinal cord injury (SCI) causes rapid and severe bone loss below the level of the injury, often leading to osteoporosis and an increased risk of fractures from minor knocks or falls. Currently, there are no highly effective treatments for this type of bone loss. This study is testing whether a drug called romosozumab — which works by blocking a protein called sclerostin that normally limits bone formation — can prevent the dramatic bone loss that follows SCI. Participants will be randomly assigned to receive either romosozumab injections for 12 months followed by a bone-strengthening infusion (zoledronic acid), or zoledronic acid alone. Bone density will be measured at regular intervals to compare how well each approach protects bone. The goal is to start treatment early, within 3 months of the injury, when bone loss is fastest. You may be eligible if you are aged 18 to 65, have had a spinal cord injury within the past 3 months, have a significant (complete or near-complete) SCI, and are able to consent to participate. People with previous bone disease, vitamin D deficiency, significant kidney disease, or certain hormonal disorders are not eligible.

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

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Interventions

This study is a randomised open-label trial which aims to determine the effects of monthly romosozumab 210 mg administered subcutaneously for 12 months followed by zoledronic acid 5 mg administered intravenously at year 1, 3 and 5 on bone mineral density (BMD), fractures, and biochemical markers of bone formation and resorption, in patients with spinal cord injury. Romosuzumab will be self-administered or administered by a formal or informal carer. Zoledronic acid will be administered by a registered nurse. Adherence will be monitored through assessment, participant diary and self-reported adherence, pharmacy dispensing, study records and attendance.