NCT00106028已完成3 期
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 20
- 主要终点
- Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
研究概览
简要总结
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OI diagnosis
- •increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.
排除标准
- •Any bisphosphonate use within one year of enrollment
研究组 & 干预措施
Placebo Daily
Placebo Comparator
placebo tablet, once a day for one year then for two years open label risedronate
干预措施: Placebo (Drug)
Risedronate Daily
Experimental
risedronate tablet, once a day for one year then for two years open label risedronate once a day
干预措施: risedronate sodium (Actonel) (Drug)
结局指标
主要结局
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
时间窗: Baseline and Month 12
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.
次要结局
- Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population(Baseline and Month 24)
- Serum BAP - Percent Change From Baseline to Month 12, ITT Population(Baseline and 12 Months)
- Percent Change From Baseline in Total Body BMD at Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Total Body BMD at Month 24, ITT Population(Baseline and Month 24)
- Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population(Baseline and Month 24)
- Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population(Baseline and Month 24)
- Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Total Body BMC at Month 36, ITT Population(Baseline and Month 36)
- Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population(Baseline and Month 24)
- Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population(Baseline and Month 24)
- Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population(Baseline and Month 36)
- Percent Change From Baseline in Total Body BMC at Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population(Baseline and Month 12)
- New Morphometric Vertebral Fracture at Month 12, ITT Population(Baseline and Month 12)
- Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT(Baseline and Month 36)
- Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population(Month 12)
- Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population(Baseline and Month 36)
- Percent Change From Baseline in Total Body BMD at Month 36, ITT Population(Baseline and Month 36)
- Percent Change From Baseline in Total Body BMC at Month 24, ITT Population(Baseline and Month 24)
- Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population(Baseline and Month 24)
- Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population(Baseline and Month 36)
- New Morphometric Vertebral Fracture at Month 36, ITT Population(Baseline and Month 36)
- Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT(Baseline and Month 12)
- Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population(Time to First Event (days) up to 12 Months)
- Serum BAP - Percent Change From Baseline to Month 36, ITT Population(Baseline and 36 Months)
- Bone Age (Years), Change From Baseline to Month 36, ITT Population(Baseline and Month 36)
- Number of Clinical Fractures, Month 12, ITT Population(12 Months)
- Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population(Baseline and Month 36)
- Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population(Baseline and Month 12)
- Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population(Baseline and Month 36)
- Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population(Baseline and Month 36)
- Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population(Month 12)
- Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population(Baseline and Month 12)
- Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population(Baseline and Month 36)
- Serum BAP - Percent Change From Baseline to Month 24, ITT Population(Baseline and 24 Months)
- Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population(Baseline and Month 24)
- Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population(Baseline and Month 36)
- Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population(Baseline and Month 12)
- Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population(Baseline and Endpoint / Month 12)
- Bone Age (Years), Change From Baseline to Month 12, ITT Population(Baseline and Month 12)
- Bone Age (Years), Change From Baseline to Month 24, ITT Population(Baseline and Month 24)
研究者
研究点 (20)
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