Investigating the effect of Romosozumab on osteoporosis following spinal cord injury

Phase 4

• Conditions: Osteoporosis; Acute Spinal Cord Injury; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Injuries and Accidents - Fractures; Musculoskeletal - Osteoporosis; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000141640
• Lead Sponsor: Princess Alexandra Hospital, Metro South Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-10
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total BMD change at the knee (distal femur) as assessed by Dual-energy X-ray absorptiometry (DXA)[Assessed at baseline and at 12 months post-randomisation];Total BMD change at the knee (proximal tibia) as assessed by Dual-energy X-ray absorptiometry (DXA)[Assessed at baseline and at 12 months post-randomisation]