The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study: 2-year nonvertebral fragility fracture results.
The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study: 2-year nonvertebral fragility fracture results.
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DOI：
10.1007/s00198-013-2284-y
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发表时间：
2013-08
影响因子：
4
通讯作者：
Krohn, K.
中科院分区：
文献类型：
--
作者：
Silverman, S.;Miller, P.;Sebba, A.;Weitz, M.;Wan, X.;Alam, J.;Masica, D.;Taylor, K. A.;Ruff, V. A.;Krohn, K.
这项观察性研究评估了4,000多名接受特立帕肽（TPTD）治疗的骨质疏松症男性和女性的非椎骨脆性骨折（NVFX）发生率。接受TPTD治疗超过6个月的患者新发NVFX的发生率降低。在这项大型试验中未观察到新的显著安全性结果。社区经验中非椎骨骨折的直接评估（DANCE）研究评价了在真实世界环境中接受TPTD治疗骨质疏松症的患者中NVFX的发生率。DANCE是一项多中心、前瞻性、观察性试验，旨在检查TPTD在研究医生认为适合TPTD治疗的骨质疏松症男性和女性患者中的长期有效性。患者每天皮下注射20 μg TPTD，持续24个月，并在治疗停止后随访24个月。在治疗和停药阶段的4个6个月期间，以>0至≤6个月作为参考，评价了患者发生新NVFX（定义为与低创伤相关的骨折）的发生率。我们还观察了严重不良事件的谱和发生率。在入组的4，167例患者中，4，085例接受了一剂或多剂TPTD（安全性人群）; 3，720例纳入疗效分析。4个治疗阶段发生NVFX的患者发生率分别为1.42、0.91、0.70和0.81%，治疗停止后4个阶段分别为0.80、0.68、0.33和0.33%。与参考期相比，每个时期的差异具有统计学显著性（前6个月间隔，每个p < 0.05）。未观察到新的显著安全性结果。在本研究中，与0至≤6个月相比，在所有3个治疗期>6个月内接受TPTD的患者的NVFX发生率均降低，并且该趋势在整个停药期持续存在。TPTD通常耐受良好。
This observational study evaluated the occurrence of nonvertebral fragility fractures (NVFX) in over 4,000 men and women with osteoporosis treated with teriparatide (TPTD). The incidence of new NVFX decreased for patients receiving TPTD treatment for greater than 6 months. No new significant safety findings were observed in this large trial. The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study evaluated the occurrence of NVFX in patients receiving TPTD for osteoporosis in a real-world setting. DANCE is a multicenter, prospective, observational trial that examined the long-term effectiveness of TPTD in men and women with osteoporosis whom study physicians judged to be suitable for TPTD therapy. Patients received 20 μg TPTD per day by subcutaneous injection for up to 24 months and were followed for 24 months after treatment cessation. The incidence of patients experiencing a new NVFX, defined as a fracture associated with low trauma, was evaluated during four 6-month periods in both the treatment and cessation phases with >0 to ≤6 months serving as the reference. We also observed the spectrum and occurrence of serious adverse events. Of the 4,167 patients enrolled, 4,085 took one or more doses of TPTD (safety population); 3,720 were included in the efficacy analysis. The incidence of patients experiencing a NVFX was 1.42, 0.91, 0.70, and 0.81 % for the four treatment periods, respectively, and 0.80, 0.68, 0.33, and 0.33 % for the four periods after treatment cessation. Differences for each period were statistically significant compared with the reference period (first 6-month interval, each p < 0.05). No new significant safety findings were observed. In this study, the incidence of NVFX decreased for patients receiving TPTD for all three treatment periods >6 months compared to 0 to ≤6 months, and this trend persisted throughout the cessation phase. TPTD was generally well tolerated.
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影响因子：
4.2
作者：
Langdahl, Bente L.;Rajzbaum, Gerald;Jakob, Franz;Karras, Dimitrios;Ljunggren, Osten;Lems, Willem F.;Fahrleitner-Pammer, Astrid;Walsh, J. Bernard;Barker, Clare;Kutahov, Alexey;Marin, Fernando
通讯作者：
Marin, Fernando
影响因子：
4
作者：
Lindsay, R.;Miller, P.;Krege, J. H.
通讯作者：
Krege, J. H.
影响因子：
4
作者：
Miller, PD;Silverman, SL;Wagman, RB
通讯作者：
Wagman, RB
影响因子：
2.3
作者：
Rajzbaum, Gerald;Jakob, Franz;Marin, Fernando
通讯作者：
Marin, Fernando
影响因子：
158.5
作者：
Neer, RM;Arnaud, CD;Mitlak, BH
通讯作者：
Mitlak, BH