ACTRN12610000507088已完成3 期
Open label, randomized clinical trial of zoledronic acid (Aclasta) versus vitamin D plus calcium in children and adolescents with Duchenne muscular dystrophy, to assess change in lumbar spine bone density over 12 months
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Years 至 16 Years（—）
- 性别
- Male
入选标准
- •All boys between 6-16 years with confirmed Duchenne Muscular Dystrophy (DMD) and who are receiving glucocorticoid therapy (this is universally prednisolone)
排除标准
- •Genant Grade 3 or greater vertebral compression
- •1. Any prior use of osteoporosis or bone-modifying therapy, such as bisphosphonates, sodium fluoride, calcitonin, calcitriol, Gonadotrophin releasing hormone agonists or Growth Hormone (GH).
- •2. Patients who have received testosterone therapy may only be included in the trial if this therapy was given as part of physiological replacement in the setting of documented hormonal deficiencies
- •3. Any prior history of malignancy
- •4. Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by DEXA evaluation in the region of interest (ROI) L1-L4, as confirmed by the central imaging laboratory, will not be considered eligible for this study.
- •5. Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at screening
- •6. Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 50 nmol/L) at screening
- •7. Renal impairment: Glomerulr filtration rate (GFR) < 35 ml/min/1.73 m2 at screening based on the Schwartz formula.
- •8. A serum creatinine increase between Visit 1 and Visit 2 greater than 44.2 mmol/L
- •9. History of hyperparathyroidism, hypothyriodism or hyperthyroidism within 1 year of screening
- •10.History of sarcoidosis, primary bone disease (osteogenesis imperfecta, idiopathic juvenile
- •osteoporosis, rickets/osteomalacia)., Kawasaki’s disease or Henoch-Schonlein Purpura.
- •11. Diagnosis of active uveitis (symptomatic or asymptomatic) at the time of enrollment of the study.
- •12. Any subject involved in another study, if an investigational agent is deemed by investigators to possible interfere with this study agent. ( for example use of a different bisphosphonate or a statin, a drug that utilizes the same biochemical pathways )
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