Takeuchi Yasuhiro, Tanaka Shiro, Kuroda Tatsuhiko, Hagino Hiroshi, Mori Satoshi, Soen Satoshi
Toranomon Hospital Endocrine Center, 2-2-2 Toranomon, Minato-Ku, Tokyo, 105-8470, Japan.
Okinaka Memorial Institute for Medical Research, Minato-Ku, Tokyo, Japan.
Osteoporos Int. 2024 Dec;35(12):2175-2182. doi: 10.1007/s00198-024-07260-9. Epub 2024 Sep 30.
The association of renal function with fracture incidence during teriparatide or alendronate treatment in elderly Japanese women was examined. Fracture incidence differed by fracture type, renal function, and treatment protocol. The results provide important information on pharmacotherapy in clinical practice for osteoporosis.
Incidence rate of morphometric vertebral fracture was lower under treatment with once-weekly teriparatide (TPTD) followed by alendronate (ALN) than under treatment with ALN throughout the study among elderly Japanese women at high fracture risk in JOINT-05. This is an exploratory subgroup analysis according to chronic kidney disease (CKD) status at baseline.
Participants received sequential therapy with TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group, N = 483) or ALN monotherapy for 120 weeks (ALN group, N = 496). Baseline CKD status was classified by the estimated glomerular filtration rate (eGFR) and categorized as: CKD 1/2 (eGFR ≥ 60 mL/min/1.73 m), CKD 3a (eGFR 45-59 mL/min/1.73 m), or CKD 3b/4 (eGFR < 45 mL/min/1.73 m). Incidences of vertebral fractures including morphometric fractures, non-vertebral fractures, and all fractures were evaluated during follow-up.
Baseline characteristics were not different between treatment groups. Higher stages of CKD were associated with age and number of prevalent vertebral fracture. In CKD 1/2 patients (N = 556 with 90 incidents of morphometric vertebral fracture), the incidence of vertebral fractures was lower in the TPTD-ALN group than in the ALN group (p = 0.01). In CKD 3b/4 patients (N = 112 with 10 incidents of non-vertebral fracture), the incidence of non-vertebral fractures was lower in the ALN group than in the TPTD-ALN group, although the number of fractures was small. In the ALN group, the incidences of vertebral fractures, non-vertebral fractures, and all fractures remained constant across CKD stages.
This exploratory analysis showed that fracture incidence on ALN was constant regardless of renal function. It also suggested that the incidence of vertebral fractures on TPTD-ALN was lower than ALN monotherapy in CKD 1/2 patients. These results provide important information for drug selection in the clinical practice of osteoporosis.
研究了日本老年女性在使用特立帕肽或阿仑膦酸盐治疗期间肾功能与骨折发生率之间的关联。骨折发生率因骨折类型、肾功能和治疗方案而异。研究结果为骨质疏松症临床实践中的药物治疗提供了重要信息。
在JOINT - 05研究中，高骨折风险的日本老年女性中，每周一次使用特立帕肽（TPTD）后再使用阿仑膦酸盐（ALN）治疗时，形态计量学椎体骨折的发生率低于全程使用ALN治疗时。这是一项根据基线慢性肾脏病（CKD）状态进行的探索性亚组分析。
参与者接受TPTD序贯治疗72周，随后接受ALN治疗48周（TPTD - ALN组，N = 483）或ALN单药治疗120周（ALN组，N = 496）。根据估计肾小球滤过率（eGFR）对基线CKD状态进行分类，分为：CKD 1/2（eGFR≥60 mL/min/1.73 m²）、CKD 3a（eGFR 45 - 59 mL/min/1.73 m²）或CKD 3b/4（eGFR＜45 mL/min/1.73 m²）。在随访期间评估椎体骨折（包括形态计量学骨折）、非椎体骨折和所有骨折的发生率。
治疗组之间的基线特征无差异。较高的CKD分期与年龄和既往椎体骨折数量相关。在CKD 1/2患者中（N = 556，有90例形态计量学椎体骨折事件），TPTD - ALN组的椎体骨折发生率低于ALN组（p = 0.01）。在CKD 3b/组中（N = 112，有10例非椎体骨折事件），尽管骨折数量较少，但ALN组的非椎体骨折发生率低于TPTD - ALN组。在ALN组中，椎体骨折、非椎体骨折和所有骨折的发生率在不同CKD分期中保持恒定。
这项探索性分析表明，无论肾功能如何，ALN治疗的骨折发生率是恒定的。还表明在CKD 1/2患者中，TPTD - ALN治疗的椎体骨折发生率低于ALN单药治疗。这些结果为骨质疏松症临床实践中的药物选择提供了重要信息。
