Service de rhumatologie, Paris Descartes University, hôpital Cochin, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France.
Joint Bone Spine. 2012 Jul;79(4):389-92. doi: 10.1016/j.jbspin.2011.05.001. Epub 2011 Jun 23.
To assess if the use of biological marker of bone resorption (CTX) feedback is a mean to improve persistence on monthly oral ibandronate.
One year prospective multicenter study using a cluster randomisation design with physicians as randomized units into two groups, A and B; in group B, physicians used results of CTX and two standardized messages according to CTX changes from baseline: suboptimal if decrease less than 30% at week 6, positive otherwise. In group A, the follow-up was standard of care. Patients were postmenopausal women, initiating a treatment with ibandronate 150 mg monthly. They were blinded to the study hypotheses and outcome. The outcome was the proportion of patients persistent at 1-year visit.
Eighty-eight physicians were randomized in group A and included 346 patients, 75 in group B included 250 patients. The persistence at 1-year was high and not different between the two groups (75.1 and 74.8% P=0.932). There was no difference in the proportion of persistent patients according to the message delivered in the group of patient with CTX information: 77.4 and 74.8% in patients with a suboptimal or positive message respectively.
This study failed to demonstrate that supporting monitoring of CTX could improve persistence to ibandronate treatment in postmenopausal osteoporosis.
Persistence is a strong determinant of anti-osteoporotic treatments efficacy. Monitoring of bone markers is not a mean to improve persistence of an oral bisphosphonate. There is a discrepancy between levels of persistence in clinical studies and real life.
评估骨吸收生物标志物（CTX）反馈的使用是否是提高每月口服伊班膦酸盐持续治疗的一种手段。
采用集群随机设计，以医生为随机单位，将 1 年前瞻性多中心研究分为两组，A 组和 B 组；B 组医生根据 CTX 从基线的变化使用 CTX 结果和两个标准化信息：如果第 6 周时降低小于 30%，则为不理想，否则为阳性。在 A 组中，随访为标准护理。患者为绝经后妇女，开始接受伊班膦酸盐 150mg 每月治疗。他们对研究假设和结果不知情。结局为 1 年就诊时患者持续治疗的比例。
A 组 88 名医生随机分组，包括 346 名患者，B 组 75 名医生包括 250 名患者。两组患者 1 年的持续治疗率均较高且无差异（75.1%和 74.8%，P=0.932）。根据 CTX 信息组中传递的信息，持续治疗患者的比例无差异：不理想或阳性信息的患者分别为 77.4%和 74.8%。
本研究未能表明支持 CTX 监测可提高绝经后骨质疏松症患者对伊班膦酸盐治疗的持续治疗率。
持续治疗是抗骨质疏松症治疗疗效的重要决定因素。骨标志物监测不是提高口服双膦酸盐持续治疗的手段。临床研究中的持续治疗率与实际生活存在差异。
