Department of Rehabilitation, Sanin Rosai Hospital, 1-8-1 Kaikeshinden, Yonago, Tottori, 683-8605, Japan.
Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
J Bone Miner Metab. 2024 May;42(3):382-388. doi: 10.1007/s00774-024-01515-5. Epub 2024 May 16.
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.
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.
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.
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.
本研究旨在评估特立帕肽(TPTD)联合阿仑膦酸钠(ALN)治疗骨质疏松症时,将骨密度(BMD)≥-2.5 SD 作为治疗目标(T2T)的效果,并通过重新分析高骨折风险的绝经后日本女性参与的一项随机对照试验(JOINT-05)的数据,探讨其与椎体骨折事件的关系。
参与者接受每周一次的 TPTD 治疗 72 周,随后接受每周一次的 ALN 治疗 48 周(TPTD-ALN 组)或连续 ALN 治疗 120 周(ALN 组)。使用双能 X 射线吸收法在 0、24、48、72 和 120 周时测量腰椎(L2-4)、全髋和股骨颈的 BMD。T2T 目标为 BMD≥-2.5 SD,终点为三个测量部位基线 BMD<-2.5 SD 的参与者中达到 BMD≥-2.5 SD 的比例。
共纳入 559 名参与者。在 TPTD-ALN 组,腰椎(L2-4)、全髋和股骨颈的 BMD 在 120 周时达到≥-2.5 SD 的比例分别为 20.5%、23.1%和 5.9%,在 ALN 组分别为 22.2%、11.7%和 7.3%。在低和高 BMD 区域均发生了椎体骨折事件。
在 1.5 年的治疗期间,超过 20%的参与者达到了腰椎(L2-4)BMD≥-2.5 SD 的 T2T 目标。由于达到的水平取决于 BMD 测量部位,因此应根据基线 BMD 水平选择合适的部位。