Gallagher J Christopher, Genant Harry K, Crans Gerald G, Vargas Socorro Juan, Krege John H
Lilly Research Laboratories, DC 6121, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana 46285, USA.
J Clin Endocrinol Metab. 2005 Mar;90(3):1583-7. doi: 10.1210/jc.2004-0826. Epub 2004 Dec 21.
The relationship between prior fractures and risk of new fractures was evaluated in 931 postmenopausal women with prevalent vertebral fractures randomized to daily placebo or teriparatide (20 mug) in the Fracture Prevention Trial. The median observation time was 21 months. Among placebo patients with one, two, or three or more prevalent vertebral fractures, 7%, 16%, and 23%, respectively, developed vertebral fractures (by Cochran-Armitage trend test, P < 0.001), and 3%, 9%, and 17% developed moderate or severe vertebral fractures (P < 0.001). Among placebo patients with mild, moderate, or severe prevalent vertebral fractures, 10%, 13%, and 28%, respectively, developed vertebral fractures (P < 0.001), and 4%, 8%, and 23% developed moderate or severe vertebral fractures (P < 0.001). Among placebo patients with zero, one, or two or more prior nonvertebral fragility fractures, 4%, 8%, and 18%, respectively, developed nonvertebral fragility fractures (P < 0.001). In the teriparatide-treated group, there was no significant increase in vertebral or nonvertebral fracture risk in these subgroups. In summary, the number and severity of prevalent vertebral fractures independently predicted the risk for new vertebral fractures, and the number of prior nonvertebral fractures predicted the risk for new nonvertebral fractures in placebo patients. However, in teriparatide-treated patients, the increased fracture risk associated with prior number and severity of fracture was not observed.
在骨折预防试验中,对931名患有椎体骨折的绝经后女性进行了评估,这些女性被随机分配至每日服用安慰剂或特立帕肽(20微克)组,以研究既往骨折与新发骨折风险之间的关系。中位观察时间为21个月。在有1处、2处或3处及以上椎体骨折的安慰剂组患者中,分别有7%、16%和23%发生了椎体骨折(通过 Cochr an - Armitage趋势检验,P < 0.001),3%、9%和17%发生了中度或重度椎体骨折(P < 0.001)。在有轻度、中度或重度椎体骨折的安慰剂组患者中,分别有10%、13%和28%发生了椎体骨折(P < 0.001),4%、8%和23%发生了中度或重度椎体骨折(P < 0.001)。在既往无椎体、有1处或2处及以上非椎体脆性骨折的安慰剂组患者中,分别有4%、8%和18%发生了非椎体脆性骨折(P < 0.001)。在特立帕肽治疗组中,这些亚组的椎体或非椎体骨折风险均未显著增加。总之,既往椎体骨折的数量和严重程度独立预测了安慰剂组患者新发椎体骨折的风险,既往非椎体骨折的数量预测了新发非椎体骨折的风险。然而,在特立帕肽治疗的患者中,未观察到与既往骨折数量和严重程度相关的骨折风险增加。