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绝经后骨质疏松症中地舒单抗骨密度反应的可变性。

Variability of Denosumab densitometric response in postmenopausal osteoporosis.

机构信息

Rhumatology Center, hôpital Pierre Paul Riquet, CHU Toulouse, 1 place du Dr Baylac, 31059, Toulouse cedex 9, France.

出版信息

Rheumatol Int. 2018 Mar;38(3):461-466. doi: 10.1007/s00296-018-3929-0. Epub 2018 Jan 23.

DOI:10.1007/s00296-018-3929-0
PMID:29362876
Abstract

The objective of our prospective study is to specify the variability of densitometric response to Denosumab, given in the second line, and to try to understand the reasons. All menopausal patients with primary osteoporosis, treated by Denosumab in our centre from 2014 to 2015, were included in this open prospective work. At T0, the patient's age, type of fracture, and previous treatments were collated. At T0 and T1, after 1 year of treatment by Dmab, a DXA of the spine and the hip and a determination of CTX were performed. Sixty-three patients aged 68.8 ± 8.3 years were included. The median number of treatments prescribed for osteoporosis before switch to Denosumab was 2.4. The median duration of these treatments was 7.2 years. At T1, CTX was less than 33 pg/ml (minimum threshold for our assay kit) in all patients. The median BMD in the spine increased by + 5.44% compared to T0. 14 patients in the upper quartile had a median BMD gain in the spine of + 11.07%. Fourteen patients in the lower quartile had a median BMD gain in the spine of + 0.6%. Only the duration of previous treatments, which was greater in the non-responder group, differed between these two groups. In the total cohort, the spinal densitometric gain was negatively correlated with the age of the patient at baseline (p = 0.04), the duration of previous treatment (p = 0.02), and positively with the CTX level (p = 0.05). The Dmab densitometric response is highly variable, partly explained by the duration of previous treatments and the level of bone resorption at initiation of treatment.

摘要

我们的前瞻性研究目的是明确地舒单抗二线治疗时的骨密度反应变异性,并尝试理解其中的原因。纳入了 2014 年至 2015 年期间在本中心接受地舒单抗治疗的所有原发性骨质疏松绝经后患者。在这项开放前瞻性研究中,收集了患者的年龄、骨折类型和既往治疗情况。在 T0 和 T1 时,在接受地舒单抗治疗 1 年后进行了腰椎和髋部的 DXA 检查和 CTX 测定。纳入了 63 名年龄 68.8±8.3 岁的患者。在转为地舒单抗治疗之前,中位数处方了 2.4 次骨质疏松治疗,中位治疗时间为 7.2 年。在 T1 时,所有患者的 CTX 均低于 33pg/ml(本试剂盒的最低检测限)。与 T0 相比,腰椎骨密度中位数增加了+5.44%。14 名患者的腰椎骨密度增加处于中位数的上四分位(+11.07%)。14 名患者的腰椎骨密度增加处于中位数的下四分位(+0.6%)。仅在上四分位组中,治疗前的治疗持续时间较长,在两组间存在差异。在总队列中,脊柱骨密度的增加与患者的基线年龄(p=0.04)、既往治疗持续时间(p=0.02)呈负相关,与 CTX 水平(p=0.05)呈正相关。地舒单抗的骨密度反应高度可变,部分原因是与既往治疗的持续时间和治疗开始时的骨吸收水平有关。

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Variability of Denosumab densitometric response in postmenopausal osteoporosis.绝经后骨质疏松症中地舒单抗骨密度反应的可变性。
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Denosumab mid-term densitometric gain in postmenopausal osteoporosis women in clinical practice: comment on "Variability of denosumab densitometric response in postmenopausal osteoporosis".临床实践中绝经后骨质疏松症女性使用地舒单抗的中期骨密度增益:对“绝经后骨质疏松症中地舒单抗骨密度反应的可变性”的评论。
Rheumatol Int. 2018 Jun;38(6):1161-1162. doi: 10.1007/s00296-018-4007-3. Epub 2018 Mar 15.

本文引用的文献

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Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates.地诺单抗或唑来膦酸用于曾接受口服双膦酸盐治疗的绝经后骨质疏松症女性。
J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70. doi: 10.1210/jc.2016-1801. Epub 2016 Jun 6.
2
The effects of switching daily teriparatide to oral bisphosphonates or denosumab in patients with primary osteoporosis.原发性骨质疏松症患者将每日一次的特立帕肽换用口服双膦酸盐或地诺单抗的效果。
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Sustained Modeling-Based Bone Formation During Adulthood in Cynomolgus Monkeys May Contribute to Continuous BMD Gains With Denosumab.
成年食蟹猴基于模型的持续骨形成可能有助于地诺单抗治疗下骨密度的持续增加。
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Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study.每年一次唑来膦酸治疗前骨质流失率与骨密度反应的关系:HORIZON-PFT扩展研究
J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
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Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study.地舒单抗对比利塞膦酸盐在阿仑膦酸钠治疗不依从的绝经后妇女中的疗效和安全性:一项随机、开放标签研究结果。
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Obstet Gynecol. 2013 Jun;121(6):1291-1299. doi: 10.1097/AOG.0b013e318291718c.
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Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial.地舒单抗对骨密度和骨转换生化标志物的影响:一项 2 期临床试验 8 年结果。
Osteoporos Int. 2013 Jan;24(1):227-35. doi: 10.1007/s00198-012-2052-4. Epub 2012 Jul 10.
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