ACTRN12614000578606终止未知
A Prospective, Randomised, Double Blind, Placebo Controlled Study To Compare The Safety And Efficacy(Percentage change from baseline in bone mineral density at the total hip at 12 months, compared with placebo) Of Subcutaneous Denosumab 60mg 6 monthly In Acute Spinal Cord Injury In Males And Females.
CGM Research Trust0 个研究点目标入组 40 人开始时间: 2014年5月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 60 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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