Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 26
- 主要终点
- Percent change in total fat mass
研究概览
简要总结
This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.
详细描述
Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).
Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have growth hormone deficiency that started in childhood or adulthood
- •Have not received any growth hormone treatment in the last 12 months
- •Have had a growth hormone stimulation test within the last two years showing abnormally low response
- •Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months
排除标准
- •Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
- •Recent growth of pituitary tumor or other intracranial tumor
- •History of acromegaly
- •Taking medication to suppress appetite or reduce weight, or antidepressant drugs
- •Poorly-controlled high blood pressure or diabetes
结局指标
主要结局
Percent change in total fat mass
时间窗: Eight months
次要结局
- Safety(Eight months)