背景:这项研究的目的是评估在使用特立帕肽(TPTD)和阿仑膦酸盐(ALN)治疗骨质疏松症时,是否可以将骨密度(BMD)≥-2.5SD用作治疗目标(T2T)目标,并通过重新分析来自随机的数据来研究与偶发椎体骨折的关系,对照试验(JOINT-05),涉及绝经后高骨折风险的日本妇女。
方法:参与者接受每周一次TPTD的序贯治疗,持续72周,随后ALN治疗48周(TPTD-ALN组)或ALN单药治疗120周(ALN组)。在腰椎(L2-4)测量BMD,全髋关节,和股骨颈在0、24、48、72和120周通过双能X线吸收法。T2T目标为BMD≥-2.5SD,终点是三个测量部位BMD≥-2.5SD的基线BMD<-2.5SD的参与者比例。
结果:共选择559名参与者。在L2-4,全髋关节,120周时BMD≥-2.5SD,股骨颈部位达到20.5%,23.1%,和5.9%,分别,在TPTD-ALN组中和22.2%,11.7%,和7.3%,分别,在ALN组中。在较低和较高BMD的区域发生了椎体骨折。
结论:在1.5年的治疗期间,超过20%的参与者在L2-4时达到BMD≥-2.5SD作为T2T目标.由于成就水平因BMD测量地点而异,应根据基线BMD水平选择合适的部位。
BACKGROUND: The purpose of this study was to evaluate whether bone mineral density (BMD) ≥ -2.5 SD could be used as the treat-to-target (T2T) goal when treating osteoporosis with teriparatide (TPTD) and alendronate (ALN), and to investigate the relationship with incident vertebral fracture by re-analyzing data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high fracture risk.
METHODS: Participants received sequential therapy with once-weekly TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group) or ALN monotherapy for 120 weeks (ALN group). BMDs were measured at the lumbar spine (L2-4), total hip, and femoral neck at 0, 24, 48, 72, and 120 weeks by dual-energy X-ray absorptiometry. The T2T goal was BMD ≥ -2.5 SD, and the endpoint was the proportion of participants with baseline BMD < -2.5 SD in three measurement sites achieving BMD ≥ -2.5 SD.
RESULTS: A total of 559 participants were selected. BMD ≥ -2.5 SD at 120 weeks in the L2-4, total hip, and femoral neck sites was achieved in 20.5%, 23.1%, and 5.9%, respectively, in the TPTD-ALN group and 22.2%, 11.7%, and 7.3%, respectively, in the ALN group. Incident vertebral fractures occurred in areas of both lower and high BMD.
CONCLUSIONS: During the 1.5-year treatment period, more than 20% of participants achieved BMD ≥ -2.5 SD as a T2T goal at L2-4. Since the achievement level differed depending on the BMD measurement site, the appropriate site should be selected according to the baseline BMD level.