NCT00004488已完成2 期
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 6
研究概览
简要总结
OBJECTIVES:
I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
详细描述
PROTOCOL OUTLINE:
This is a randomized, double blind, placebo controlled study.
All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months.
Patients are followed every 6 months for 2 years.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency
- •Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months
- •Lumbar spine bone density below the mean for age, sex, and race
- •-Prior/Concurrent Therapy--
- •At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen
- •-Patient Characteristics--
- •Renal: No chronic renal failure; No recurrent renal stones
- •Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment
- •Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
排除标准
- 未提供
研究者
研究点 (6)
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