Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To assess the effect of zoledronic acid on preventing incident vertebral fractures
研究概览
简要总结
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or subject's legally acceptable representative has provided informed consent.
- •Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
- •Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
- •children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on MRI of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation OR
- •children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on MRI that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by MRI) and/or knee pain (in the case of osteonecrotic lesions, identified by MRI).
排除标准
- •Any child for whom the treating physician feels participation is not advised.
- •Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
- •Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
- •Children with renal failure (eGFR<60ml/min/1.73m2).
- •Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
- •Children with hypocalcemia.
- •Children planning dental procedures and/or dental surgery during the course of the study.
- •Children with asthma who are acetylsalicylic acid (ASA) sensitive.
- •Children with a documented history of atrial fibrillation.
- •Currently pregnant or planning a pregnancy during the study.
- •Currently breastfeeding or planning on breastfeeding during the study.
研究组 & 干预措施
Intravenous Zoledronic Acid
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
To assess the effect of zoledronic acid on preventing incident vertebral fractures
时间窗: 15 months post-diagnosis (12 months after baseline visit)
To assess the effect of zoledronic acid on preventing incident vertebral fractures as measured by lateral spine radiographs at 15 months post-diagnosis compared to baseline (with baseline occurring 3 months post-diagnosis). An incident vertebral fracture on lateral spine radiographs will be defined as a new fracture (Genant Grade 1 or more) in a previously normal vertebral body, or worsening of an existing fracture (increase in Genant Grade by at least 1) on the follow-up x-ray that takes place 12 months after the first dose.
次要结局
未报告次要终点
研究者
Dr. Leanne Ward
MD
Children's Hospital of Eastern Ontario