Guelman Rodolfo, Sánchez Ariel, Varsavsky Mariela, Brun Lucas R, García María Laura, Sarli Marcelo, Paula Rey, Farias Vanina, Zanchetta María Belén, Giacoia Evangelina, Salerni Helena, Maffei Laura, Premrou Valeria, Oliveri Beatriz, Brance María Lorena, Pavlove Magdalena, Karlsbrum Silvia, Larroudé María Silvia, Costanzo Pablo René
Servicio de Endocrinología y Medicina Nuclear, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Centro de Endocrinología, Rosario, Argentina.
Int J Endocrinol. 2023 Jan 13;2023:9355672. doi: 10.1155/2023/9355672. eCollection 2023.
To evaluate the effect of teriparatide (TPTD) on bone mineral density (BMD) and bone markers under clinical practice conditions. To assess whether the results in real-life match those published in clinical trials.
Cross-sectional study of postmenopausal women treated with TPTD for at least 12 months.
264 patients were included in the study. Main characteristics are as follows: age: 68.7 ± 10.2 years, previous fractures: 57.6%, and previously treated with antiresorptive (AR-prior): 79%. All bone turnover markers studied significantly increased after 6 months. CTX and BGP remained high up to 24 months, but total and bone alkaline phosphatase returned to basal values at month 18. There was a significant increase in lumbar spine (LS) BMD after 6 months (+6.2%), with a maximum peak at 24 months (+13%). Femoral neck (FN) and total hip (TH) BMD showed a significant increase later than LS (just at month 12), reaching a maximum peak at month 24 (FN + 7.9% and TH + 5.5%). A significant increase in LS BMD was found from month 6 to month 24 compared to basal in both AR-naïve, and AR-prior patients (+16.7% and +10.5%, respectively), without significant differences between the two groups. Comparable results were found in FN and TH BMD. . As reported in real-life clinical studies, treatment of osteoporotic postmenopausal women with TPTD induced a significant increase in bone turnover markers from month 6 onward and an increase in BMD from months 6-12 with continuous gain up to month 24. The real-life results of our study matched the results of randomized clinical trials. In addition, TPTD induced an increase in BMD, regardless of the previous use of AR.
评估在临床实际条件下特立帕肽(TPTD)对骨密度(BMD)和骨标志物的影响。评估现实生活中的结果是否与临床试验中发表的结果相符。
对接受TPTD治疗至少12个月的绝经后妇女进行横断面研究。
264例患者纳入研究。主要特征如下:年龄:68.7±10.2岁,既往骨折:57.6%,既往接受抗吸收治疗(既往使用抗吸收药物):79%。所有研究的骨转换标志物在6个月后均显著升高。CTX和BGP在24个月时仍保持高位,但总碱性磷酸酶和骨碱性磷酸酶在第18个月时恢复到基础值。腰椎(LS)骨密度在6个月后显著增加(+6.2%),在24个月时达到最大峰值(+13%)。股骨颈(FN)和全髋(TH)骨密度的显著增加晚于腰椎(仅在第12个月),在第24个月时达到最大峰值(FN +7.9%,TH +5.5%)。与基础值相比,在未使用过抗吸收药物和既往使用过抗吸收药物的患者中,从第6个月到第24个月LS骨密度均显著增加(分别为+16.7%和+10.5%),两组之间无显著差异。在FN和TH骨密度方面也发现了类似结果。正如在现实生活临床研究中所报道的,用TPTD治疗骨质疏松性绝经后妇女从第6个月起骨转换标志物显著增加,从第6 - 12个月骨密度增加,并持续增加直至第24个月。我们研究的现实生活结果与随机临床试验结果相符。此外,无论先前是否使用抗吸收药物,TPTD均可导致骨密度增加。