The Effects of Denosumab (study medication) versus Placebo (Dummy medication) on Bone Density in People who have had a Spinal Cord Injury

Not Applicable

• Conditions: Spinal Cord Injury; Bone loss; Injuries and Accidents - Fractures; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12614000578606
• Lead Sponsor: CGM Research Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified