None listed
Conditions
Brief 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.
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 regi
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.
Sponsors
Princess Alexandra Hospital, Metro South Health
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years to 65 years (upper age limit is to reduce the influence of age on ability of the skeleton to respond to pharmacologic stimulation and reduce the risk of losing participants to follow-up) - Within 3 months of acute SCI - American Spinal Injury Association (ASIA) Impairment Scale A-C - People with SCI and traumatic brain injury will be included if they are able to provide informed consent
Exclusion criteria
- Unable or unwilling to provide informed consent (consent not granted by substitute decision maker) or comply with follow-up and study protocol. - History of prior bone disease (i.e., Paget’s disease, primary hyperparathyroidism, current or previously treated osteoporosis) - Documented heterotopic ossification (HO) - Endocrinopathies (including untreated hyperthyroidism, active Cushing’s Syndrome, hypocalcaemia) - Chronic kidney disease (glomerular filtration rate 20% - Life expectancy less than 5 years - Organ transplant recipients - Chronic glucocorticoid use for glucocorticoid-responsive medical conditions (not including physiological replacement) - Vitamin D levels lower than 50 nmol/L
Outcome results
None listed