Leere Julius Simoni, Majgaard Jens, Leere Marianne Zacho Prieß, Overby Anne Camilla, Vestergaard Peter
Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.
Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark; Steno Diabetes Center North Jutland, Aalborg, Denmark.
Endocr Pract. 2022 Dec;28(12):1226-1231. doi: 10.1016/j.eprac.2022.09.006. Epub 2022 Oct 25.
We investigated the development in the primary outcomes: changes in bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, and femoral neck after 2 years.
In patients with primary hyperparathyroidism, we investigated the effects of 30-mg cinacalcet per day plus 60 denosumab every 6 months for 1 year (Deno group), versus denosumab plus placebo for 1 year (DenoPlacebo-group), versus placebo plus placebo injection for 1 year (Placebo group). After the study's termination, most patients receiving denosumab were switched to bisphosphonate treatment.
Forty-three out of 45 participants were subject to follow-up. A total of 35 patients completed a 2-year follow-up dual x-ray absorptiometry-scan (Deno: n = 13; DenoPlacebo: n = 12; and Placebo: n = 10). None of the groups showed statistically significant changes in BMD or experienced decreases in mean BMD below the study's baseline level. Overall, the changes in T-scores from the final study measurement to follow-up were similar among the groups (P = .38 for lumbar spine T-score, .63 for total hip, and .97 for femoral neck by 1-way ANOVA). P-calcium was not different over time (P = .20 for change over time and P = .08 for the difference between the groups by repeated measures ANOVA). A total of 5 participants suffered a fracture during the study or follow-up periods, all but one was in the placebo group.
Evidence suggests that it is possible to at least maintain BMD, and thus potentially lower the fracture risk by a short course of denosumab followed by antiresorptive therapy, where applicable in patients with primary hyperparathyroidism.
我们研究了主要结局指标的变化情况：通过双能X线吸收法测量腰椎、全髋和股骨颈的骨密度（BMD）在2年后的变化。
在原发性甲状旁腺功能亢进患者中，我们研究了每日30毫克西那卡塞加每6个月60毫克地诺单抗治疗1年（地诺单抗组）、地诺单抗加安慰剂治疗1年（地诺单抗-安慰剂组）、安慰剂加安慰剂注射治疗1年（安慰剂组）的效果。研究结束后，大多数接受地诺单抗治疗的患者改用双膦酸盐治疗。
45名参与者中有43名接受了随访。共有35名患者完成了为期2年的随访双能X线吸收法扫描（地诺单抗组：n = 13；地诺单抗-安慰剂组：n = 12；安慰剂组：n = 10）。所有组的骨密度均未显示出统计学上的显著变化，且平均骨密度均未降至研究基线水平以下。总体而言，各组从最终研究测量到随访时的T值变化相似（单因素方差分析显示，腰椎T值P = 0.38，全髋P = 0.63，股骨颈P = 0.97）。血清钙随时间无差异（重复测量方差分析显示，随时间变化P = 0.20，组间差异P = 0.08）。共有5名参与者在研究或随访期间发生骨折，除1名外均在安慰剂组。
有证据表明，对于原发性甲状旁腺功能亢进患者，在适用的情况下，通过短期使用地诺单抗然后进行抗吸收治疗，至少有可能维持骨密度，从而潜在降低骨折风险。
