NCT00010439已完成2 期
A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Increased Bone Mineral Density
研究概览
简要总结
OBJECTIVES:
I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.
详细描述
PROTOCOL OUTLINE:
Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20%).
- •Bone mineral density by DXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip)
- •Parental consent (and patient assent after age 12 years) to participate in the study.
- •Sexual development at Tanner stage II or less (Prepubertal stage)
- •Weight 20kg and more
排除标准
- •History of severe gastritis or reflux
- •Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes.
- •Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia)
- •Hypersensitivity to bisphosphonates
- •Uncorrected hypocalcemia
- •History of gastric or duodenal ulcers
- •Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL
- •Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL
- •Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness
- •Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase > 2 times normal for age
- •Severe gastritis or reflux
- •Pregnancy
- •Anorexia Nervosa
- •Prior/Concurrent Therapy-
- •Prior course of prednisone allowed
- •No concurrent prednisone except inhaled steroids
- •No concurrent high-dose glucocorticoids
- •No concurrent salmon calcitonin
- •No other concurrent bisphosphonates
- •No concurrent long-term anti-seizure medication
研究组 & 干预措施
1 Alendronate for 12 months
Experimental
Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
干预措施: Alendronate (Drug)
结局指标
主要结局
Number of Participants With Increased Bone Mineral Density
时间窗: at 12 months
Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)
次要结局
- Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.(Before and 12 months after treatment with alendronate)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The effect of Alendronate on bone mineral density in the acetabulum and proximal femur after cementless total hip arthroplastyPost hip arthroplastyJPRN-UMIN000004847Juntendo University Nerima Hospital36
已完成
不适用
Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related OsteoporosisCystic FibrosisOsteoporosisNCT00004489University of North Carolina60
已完成
2 期
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's DiseaseGaucher's DiseaseOsteopeniaNCT00004488Children's Hospital Medical Center, Cincinnati82
已完成
4 期
Effects of long-acting alendronate on osteoporosis with impaired glucose metabolismOsteoporosisJPRN-UMIN000000987ational Hospital Organization, Kyoto Medical Center100
进行中（未招募）
不适用
Effect of alendronate on spontaneous osteoclastogenesis in postmenopausal osteoporosis - ALENDRONATEMedDRA version: 6.1Level: PTClassification code 10031285postmenopausal osteoporosisEUCTR2006-001796-37-ITAZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO30