NCT00798473已完成3 期
A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Lumbar spine density by DEXA
研究概览
简要总结
Background:
- Up to 30% of children and adolescents with Crohn's disease have decreased bone strength, or decrease bone density, called osteopenia.
- Bisphosphonates are a group of drugs that have been well studied and found to be effective in the treatment of osteopenia in menopausal women.
- Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to administer, and has been found effective in the treatment of menopausal women with osteopenia.
Hypothesis: The investigators hypothesize that zoledronate can improve bone density in children and adolescents with Crohn's disease with osteopenia.
详细描述
- This study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven abnormal bone density as measured on a special type of x-ray called a DEXA-scan.
- Participants are allocated at random to one of two groups: either treatment with zoledronate, or a placebo.
- Neither the participants or the physicians are aware of which group each participant is in.
- Participants are followed every three months for one year, and assessed with blood tests, urine tests, physical examination, diet questionnaire and exercise questionnaire.
- Participants have a repeat DEXA scan at 6 and 12 months after beginning the study.
- Once all participants are enrolled and followed for one whole year, we will compare the bone density of the group treated with zoledronate with the group treated with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 6 to 18,
- •diagnosed with Crohn's disease with osteopenia,
- •a minimum of 6 months of adequate calcium and vitamin D intake. (Osteopenia was defined for the purposes of this study as: Z-score lumber spine BMD by DEXA of -2.0 or less, or -1.5 and a risk factor (either steroid use for 6 months or more or decrease of 0.5 z-score in the preceding 12 months).)
排除标准
- •renal dysfunction,
- •insufficient calcium or vitamin D intake,
- •current medication or condition affecting bone metabolism,
- •documented fracture, previously diagnosed bone disease,
- •documented intolerance/hypersensitivity to bisphosphonates,
- •previous treatment with bisphosphonates within the last 6 months.
研究组 & 干预措施
1
Experimental
Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
干预措施: zoledronic acid (Drug)
2
Placebo Comparator
IV saline infusion
干预措施: IV saline infusion (Other)
结局指标
主要结局
Lumbar spine density by DEXA
时间窗: 6 months
次要结局
- Duration of effect by urinary bone metabolite markers(6, 12 months)
- safety and tolerability (side-effects, renal and liver function, biochemical parameters)(0, 3, 6, 12 months)
- Lumbar spine bone density(12 months)
- Total body bone density(12 months)
- Fractures(0,3,6,12 months)
研究者
研究点 (1)
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