Investigating the effect of Romosozumab on osteoporosis following spinal cord injury

Princess Alexandra Hospital, Metro South Health0 个研究点目标入组 30 人开始时间: 2023年2月10日最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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

•-Unable or unwilling to provide informed written consent 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)
•-Severe underlying chronic disease (including COPD, end-stage cardiac failure, chronic kidney (glomerular filtration rate <35ml/min) or liver failure (liver function tests >twice upper limit of normal)
•-Chronic alcohol abuse
•-Pregnancy, or planning pregnancy or breastfeeding
•-Current diagnosis of cancer, including osteosarcoma
•-Myocardial infarction or stroke within the preceding year and/or high cardiovascular risk, 10 years Framingham score >20%
•-Life expectancy less than 5 years

发起方

Princess Alexandra Hospital, Metro South Health