None listed
Conditions
Brief summary
Participants in this study will have recently suffered a spinal cord injury. The study is using a medication to try to prevent the bone loss that occurs in people who have had this type of injury. This bone loss predisposes people to the risk of fracture. It is a twelve month study of blinded medication followed by 12 months of open label medication – 24 months in total. Study visits occur at baseline, month 3 month 6 month 12 month 18 and month 24.The study is comparing the study medication (Denosumab) to placebo (dummy medicine)in the first year. In the second year of the study all participants will receive active study medication. The medication is given by an injection under the skin once every 6 months. Participants in this study will have blood testing, measurement of bone density and renal ultrasound measurements.
Interventions
Denosumab 60 mg subcutaneous injection 6 monthly - arm 1
Matched placebo - arm 2
At the end of year one both arms can receive open label denosumab 60mg by subcutaneous injection for the second year of the study. Blinded injections at baseline and 6 months. Open label denosumab at 12 and 18 months.
Sponsors
CGM Research Trust
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Traumatic Spinal Cord Injury, Male or Female 2. Aged 25-60 years. Skeletally mature males and females 3. Within a minimum of 7 and a maximum of 10 days of injury unless participant has to wait for fracture fixation, in which case this may be extended. 4. Women of childbearing potential must be using 2 highly effective methods of birth control and to continue this practice for 7 months after last injection of study medication. 5. Participant has provided informed consent prior to any study specific procedures.
Exclusion criteria
1. Clinically significant indications of heterogeneous ossification. 2. History of osteonecrosis of the jaw and/or recent tooth extraction or dental surgery. 3. History of solid organ or bone marrow transplant. 4. Inability to tolerate DXA measurement. 5. On other treatment affecting bone turnover including the use of zoledronic acid or other bishphospohates within the year preceding study entry. 6. Serum 25-OH D <12 ng/ml 7. History of renal calculi 8. Patient is in the opinion of the investigator mentally or legally incapacitated and unable to give informed consent. 9. Significant malabsorption including Coeliac Disease, Short Bowel Syndrome, Crohn’s Disease, Previous Gastric Bypass. 10. Participation in another clinical trial 11. Active cancer and/or malignancy in last 5 years (except cervical carcinoma in situ or basal cell carcinoma) 12. Metabolic bone disease including hyperparathyroidism, hypo or hypercalcaemia, Paget’s disease, osteomalacia or osteogenesis imperfecta. 13. History of hypersensitivity or intolerance to the active substance- to CHO derived Proteins 14. Known intolerance to calcium supplements 15. Severely ill patients defined as: a. Respiratory failure/ Ventilator dependency b. Acute renal failure c. Presence of severe infection d. Multiple fractures affecting ability to rehabilitate 16. Pregnancy and/or currently lactating 17. T-score of -2.5 or lower on BMD at total hip or lumbar spine 18. Documented hypocalcaemia- a value of <2.1 (corrected calcium)mmol/L 19. eGFR <30ml/minute 20. Elevated transaminases more than or equal to 2.0 x upper limit of normal (ULN); Elevated total bilirubin (TBL) > 1.5 x ULN 21. Any condition or illness (acute, chronic, or history), which in the opinion of the Investigator might interfere with the evaluation of efficacy and safety during the study or may otherwise compromise the safety of the subject 22. Currently enrolled in or has not yet completed at least 1 month since ending another trial
Outcome results
None listed