Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.
Arch Osteoporos. 2021 Apr 15;16(1):70. doi: 10.1007/s11657-021-00933-6.
This 6-month pilot study in osteoporotic postmenopausal women evaluated cyclic TPD/RLX compared to daily subcutaneous TPD with the concept of optimizing bone formation. Compared to daily subcutaneous TPD, cyclic therapy showed comparable increase in spine BMD and favorable effects on total proximal femur BMD and cortical thickness.
There is no cure for osteoporosis; better medications or different approaches with current agents are needed. We hypothesized that monthly cycles of teriparatide (TPD) followed by raloxifene (RLX) might promote ongoing bone formation. Additionally, as TPD might initially adversely affect hip BMD, such effects may be mitigated by a cyclic approach. Therefore, this 6-month pilot study evaluated the effect of cyclic TPD/RLX compared to daily subcutaneous TPD on bone markers, BMD, trabecular bone score (TBS), and hip parameters assessed by 3D modeling.
Postmenopausal osteoporotic women (n=26) were randomized to open-label TPD 20 daily or alternating monthly cycles of TPD followed by monthly RLX 60 mg daily. BMD was measured at the lumbar spine (LS), femur, and radius by DXA. To further assess LS BMD, QCT and opportunistic CT (L1 Hounsfield units [HU]) were performed. LS TBS and hip cortical and trabecular parameters were assessed using DXA. Baseline group comparisons were performed by unpaired T-test with change over time evaluated by repeated measures ANOVA.
Participant mean age, BMI, and lowest T-score were 67.0 years, 26.0 kg/m, and -2.7; no between-group differences in serum chemistries, 25(OH)D, or BMD were observed. LS-BMD increased (p<0.001) with TPD or TPD/RLX as measured by DXA (4.8%/5.2%), QCT (13%/9.4%), or HU (15.6%/10.2%) with no between-group difference. TPD/RLX produced beneficial between-group differences in total proximal femur BMD (1.5%, p<0.05) and cortical thickness (1.6%, p<0.05).
Compared with daily TPD, cyclic TPD/RLX comparably increased spine BMD and might have favorable effects on proximal femur BMD and cortical thickness.
骨质疏松症无法治愈，需要更好的药物或利用现有药物的不同方法。我们假设每月使用特立帕肽（TPD）序贯每日使用雷洛昔芬（RLX）可能会促进骨形成。此外，由于 TPD 最初可能对髋部 BMD 产生不利影响，因此这种影响可能会通过周期性方法减轻。因此，本 6 个月的试验研究评估了与每日皮下 TPD 相比，TPD/RLX 的周期性治疗对骨标志物、BMD、骨小梁评分（TBS）和通过 3D 建模评估的髋部参数的影响。
绝经后骨质疏松女性（n=26）被随机分配至接受每日皮下 TPD 20μg 或 TPD 每月交替 2 个周期序贯每月 RLX 60mg 治疗。通过 DXA 测量腰椎（LS）、股骨和桡骨的 BMD。为了进一步评估 LS BMD，进行了 QCT 和机会性 CT（L1 体素 HU）。使用 DXA 评估 LS TBS 和髋部皮质和小梁参数。使用未配对 T 检验进行组间基线比较，并通过重复测量方差分析评估随时间的变化。
参与者的平均年龄、BMI 和最低 T 评分分别为 67.0 岁、26.0kg/m 和-2.7；血清化学、25（OH）D 或 BMD 无组间差异。LS-BMD 增加（p<0.001），DXA（4.8%/5.2%）、QCT（13%/9.4%）或 HU（15.6%/10.2%）测量的 TPD 或 TPD/RLX 治疗，组间无差异。TPD/RLX 治疗在总股骨近端 BMD（1.5%，p<0.05）和皮质厚度（1.6%，p<0.05）方面产生了有益的组间差异。
与每日 TPD 相比，TPD/RLX 同样增加了脊柱 BMD，可能对股骨近端 BMD 和皮质厚度有有利影响。
