Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita-15, Nishi-7, Kita-ku, Sapporo, 060-8638, Japan.
Department of Orthopaedic Surgery, Hokushokai Hospital, Iwamizawa, Japan.
J Bone Miner Metab. 2019 Mar;37(2):351-357. doi: 10.1007/s00774-018-0928-x. Epub 2018 May 2.
The aims of this study are to investigate changes in serum calcium (Ca) level after switching from either non-therapy, bisphosphonate, selective estrogen receptor modulators (SERM) or teriparatide treatments to a combination therapy of denosumab (DMAb), and eldecalcitol, and the association between early changes in serum calcium and changes in bone metabolic markers and bone mineral density (BMD). 129 patients with postmenopausal osteoporosis (32 non-pretreatment, 50 bisphosphonates, 18 SERM, and 29 teriparatide) were recruited and switched to DMAb plus eldecalcitol. Serum calcium levels, bone metabolism markers, and BMD measurements of the lumbar spine and femoral neck were evaluated. All groups showed an increase in BMD 6 months and 1 year after DMAb administration compared to baseline via suppression of bone metabolism markers. The TPD group showed a significant decrease in serum calcium level 1 week after the first injection of DMAb and eldecalcitol compared to baseline and the bisphosphonate group. Changes in serum calcium level from baseline to 1 week after the first injection of DMAb trended to correlate with changes in bone metabolism markers and lumbar BMD. The risks of DMAb-induced hypocalcemia are different between starting and switching from bone resorption inhibitors and bone formation promoters. Therefore, appropriate assessment before administration of DMAb, including pretreatment therapy as well as serum Ca and bone metabolic markers will help identify the risk of hypocalcemia following DMAb in combination with eldecalcitol. Our findings also showed that early change in serum Ca level after DMAb initiation could potentially predict the efficacy for therapy reaction.
本研究旨在探讨从非治疗药物、双膦酸盐、选择性雌激素受体调节剂（SERM）或特立帕肽治疗转换为地舒单抗（DMAb）联合艾地骨化醇治疗后血清钙（Ca）水平的变化，以及早期血清钙变化与骨代谢标志物和骨矿物质密度（BMD）变化之间的关系。招募了 129 例绝经后骨质疏松症患者（32 例未治疗，50 例双膦酸盐，18 例 SERM，29 例特立帕肽），并转换为 DMAb 联合艾地骨化醇治疗。评估血清钙水平、骨代谢标志物和腰椎及股骨颈的 BMD。与基线相比，所有组在 DMAb 给药后 6 个月和 1 年均显示 BMD 增加，通过抑制骨代谢标志物。与基线和双膦酸盐组相比，TPD 组在首次注射 DMAb 和艾地骨化醇后 1 周的血清钙水平显著降低。从基线到首次注射 DMAb 后 1 周的血清钙水平变化与骨代谢标志物和腰椎 BMD 的变化趋势相关。从骨吸收抑制剂和骨形成促进剂开始和转换使用 DMAb 引起低钙血症的风险不同。因此，在使用 DMAb 之前进行适当的评估，包括预处理治疗以及血清 Ca 和骨代谢标志物，将有助于识别 DMAb 联合艾地骨化醇治疗后低钙血症的风险。我们的研究结果还表明，DMAb 起始后早期血清 Ca 水平的变化可能潜在地预测治疗反应的效果。
