NCT00082511已完成3 期
A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Genelabs Technologies44 个研究点 分布在 2 个国家目标入组 114 人开始时间: 2003年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 44
- 主要终点
- Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
研究概览
简要总结
Open label safety and efficacy follow-up.
详细描述
This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-
- •Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
- •Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.
排除标准
- •Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
- •Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).
- •MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY
- •Calcitonin
- •Bisphosphonates
- •Fluoride at pharmacologic dose
- •Strontium at pharmacologic dose
- •Estrogenic steroids (except oral contraceptives)
- •Selective Estrogen Receptor Modulator (raloxifene)
- •Parathyroid hormone
- •Any androgens, including prescription or nutritional supplement DHEA, other than study drug
- •Additional Calcium supplements other than those prescribed as part of this study
结局指标
主要结局
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (44)
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