ACTRN12610000281099招募中未知
The efficacy and safety of zoledronate in children and adolescents with chronic neurological conditions and osteoporosis: a crossover trial with long term follow up.
Princess Margaret Hospital for Children0 个研究点目标入组 10 人开始时间: 2010年4月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Children and adolescents eligible to participate in the study must be:
- •1. Diagnosed with a chronic neurological condition.
- •2. Aged = 4 years to < 18, inclusive
- •3. Have an increased risk of fractures as defined by BMD <-2.5 at one or more sites and, a history of at least one radiologically confirmed, non traumatic or low impact fracture and/or significant bone pain (as determined by appearing to be in pain after other causes of pain have been excluded)
- •4. Able and willing to participate in the study as evidenced by a parent/ legal guardian signing a valid written consent form.
- •5. All pre existing factors which could contribute to a reduction in BMD such as diet, sunlight exposure, anticonvulsant medication and weight bearing programme have been addressed 6 months prior to commencement of infusion.
- •6. If female, must have a negative serum pregnancy test at baseline and be using effective contraception if sexually active.
排除标准
- •EXCLUSION CRITERIA
- •1. Body weight < 10kg.
- •2. History of cancer within past five years.
- •3. Untreated rickets within one year of treatment.
- •4. Documented history of an abnormal or allergic reaction to bisphosphonates.
- •5. Pubertal delay.
- •6. Clinically significant abnormal laboratory finding at screening
- •- Abnormal liver function tests – Alanine Amino Transferase (ALT) & Aspartate Amino Transferase (AST) > 2x upper limit of normal.
- •- Abnormal thyroid stimulating hormone (TSH) and/ or parathyroid hormone (PTH).
- •- Serum 25 (OH) vitamin D < 20 nmol/
研究者
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