SOMATROPIN TREATMENT ON BONE MINERAL DENSITY FOR ADULT ONSET GRWTH HORM DEF

这项研究考察了生长激素治疗对成人发作性生长缺陷患者骨密度的影响。以下假设将得到检验：在两年的治疗结束时，接受生长激素治疗的成人型生长激素缺乏症患者的脊柱骨密度(BMD)将高于接受安慰剂治疗的患者。在两年的治疗结束时，使用生长激素治疗的成人起病生长激素缺乏症患者的髋部骨密度将高于使用安慰剂治疗的患者。与接受安慰剂治疗的患者相比，接受生长激素治疗的成人起病生长激素缺乏症患者将表现出骨形成增加和骨破坏减少，这是通过血清和尿液标记物评估的。这些研究的具体目的是：在一项为期两年的成人生长激素缺乏症患者的随机试验中，比较生长激素治疗与安慰剂治疗对骨密度以及骨形成和骨分解的血清和尿液标志物的影响；评估成人生长激素缺乏症患者使用生长激素治疗两年的不良事件；将骨密度变化与全身成分的变化联系起来；以及，收集有关生长激素缺乏症的新的健康相关生活质量问卷的数据。

This study examines the effects of somatropin therapy on bone mineral density in patients with adult-onset growth deficiency. The following hypotheses will be tested: Patients with adult-onset growth hormone deficiency who are treated with somatropin will have a greater bone mineral density (BMD) of the spine compared to patients who are treated with placebo, at the end of 2 years of treatment. Patients with adult-onset growth hormone deficiency who are treated with somatropin will have a greater bone mineral density in the hip than patients who are treated with placebo, at the end of 2 years of treatment. Patients with adult-onset growth hormone deficiency who are treated with somatropin will demonstrate increased bone formation and decreased bone breakdown, as assessed by serum and urinary markers, compared to patients treated with placebo. The specific aims are to: Compare effects of somatropin therapy vs. placebo therapy on bone mineral density and serum and urinary markers of bone formation and bone breakdown in a randomized trial of patients with adult-onset growth hormone deficiency over two years of treatment; Assess adverse events associated with 2 years of somatropin treatment in patients with adult-onset growth hormone deficiency; Correlate BMD changes with changes in total body composition; and, Collect data on a new health-related quality of life questionnaire for somatropin deficiency syndrome.