Effects of oral alendronate on BMD in adult patients with osteogenesis imperfecta: A 3-year randomized placebo-controlled trial
Effects of oral alendronate on BMD in adult patients with osteogenesis imperfecta: A 3-year randomized placebo-controlled trial
复制标题
DOI：
10.1359/jbmr.051015
复制
发表时间：
2006-02-01
影响因子：
6.2
通讯作者：
Meunier, PJ
中科院分区：
文献类型：
--
作者：
Chevrel, G;Schott, AM;Meunier, PJ
简介：本研究评估了口服阿仑膦酸钠对成骨不全成年患者骨密度的影响。材料和方法：我们对64例成骨不全的成人患者进行了为期3年、随机、双盲、安慰剂对照的口服阿仑膦酸钠试验。主要终点是两组间3年腰椎骨密度平均变化百分比的差异。次要结局包括全髋、椎体和外周骨折发生率、疼痛、听力损失和骨转换生化指标的变化。患者每天接受安慰剂或10mg阿仑膦酸钠治疗。所有人每天都摄入1克钙和800国际单位维生素D。结果：阿仑膦酸钠组和安慰剂组腰椎骨密度平均+/- SD增加分别为10.1 +/- 9.8% （p < 0.001）和0.7 +/- 5.7%。阿仑膦酸钠组髋部骨密度升高3.3 +/- 0.5% (p = 0.001)，安慰剂组降低0.3 +/- 0.6%。样本量不足以确定阿仑膦酸钠对骨折率的影响。在意向治疗分析中，阿仑膦酸钠组疼痛评分显著增加（p = 0.04），但在每个方案分析中没有。两组的听力都没有变化。阿仑膦酸钠组骨吸收和骨形成生化指标显著降低（p < 0.001）。两组间严重不良反应无差异，但阿仑膦酸钠组非严重上胃肠道不良反应增加（p = 0.003）。结论：口服阿仑膦酸钠增加骨密度，增加非严重胃肠道不良反应，但不能改善成骨不全成年患者的听力损失。需要更多的研究来评估其对骨折率的影响。
Introduction: This study evaluated the effect of oral alendronate on the BMD of adult patients with osteogenesis imperfecta.Materials and Methods: We carried out a 3-year, randomized, double-blind, placebo-controlled trial of oral alendronate in 64 adult patients with osteogenesis imperfecta. The primary endpoint was the difference between the groups in the mean percent change in lumbar spine BMD at 3 years. Secondary outcomes included changes in BMD of total hip, vertebral and peripheral fracture incidence, pain, hearing loss, and bone turnover biochemical markers. Patients were treated daily with either placebo or 10 mg alendronate. All received 1 g of calcium and 800 IU of vitamin D daily.Results: The mean +/- SD increases in the lumbar spine BMD were 10.1 +/- 9.8% (p < 0.001) and 0.7 +/- 5.7% in the alendronate and placebo groups, respectively. Hip BMD increased in the alendronate group by 3.3 +/- 0.5% (p = 0.001) and decreased in the placebo group by 0.3 +/- 0.6%. The sample size was not sufficient to determine an effect of alendronate on fracture rate. A significant increase of the pain score was noted in the alendronate group (p = 0.04) in the intent-to-treat analysis but not in the per protocol analysis. There was no change in hearing in either group. Bone resorption and formation biochemical markers were significantly decreased in the alendronate group (p < 0.001). There were no differences in severe adverse effects between the groups, but there was an increase in nonsevere upper gastrointestinal effects in the alendronate group (p = 0.003).Conclusions: Oral alendronate increases BMD and increase nonsevere gastrointestinal adverse effects but does not modify the hearing loss in adult patients with osteogenesis imperfecta. More studies are needed to evaluate an effect on the fracture rate.