Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) Study
Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) Study
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DOI：
10.1007/s00198-005-1915-3
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发表时间：
2006-01-01
影响因子：
4
通讯作者：
Wagman, RB
中科院分区：
文献类型：
--
作者：
Miller, PD;Silverman, SL;Wagman, RB
随机安慰剂对照临床试验的经验可能与社区实践不同。关键性特立帕肽[rhPTH（1-34）]研究是在骨质疏松症的治疗选择很少时启动的。社区经验中非椎体骨折的直接分析（DANCE）研究是一项前瞻性观察性试验，旨在检查接受特立普替林治疗的大量不同患者人群中非椎体脆性骨折的发生率。还将检查临床椎骨骨折和背痛的发生率，以及骨矿物质密度、骨矿物质含量、骨面积、安全性和耐受性。将对受试者进行长达24个月的特立帕肽治疗疗程随访，并在停止治疗后再随访24个月。因此，受试者可参加本研究长达48个月。DANCE将提供有关特立帕肽治疗在临床实践中的有效性和耐受性的数据，这将补充已发表的对照临床试验的结果。
The experience in randomized placebo-controlled clinical trials may differ from that in community practice. The pivotal teriparatide [rhPTH(1-34)] studies were initiated when few therapeutic options for osteoporosis were available. The Direct Analysis of Non-Vertebral Fractures in Community Experience (DANCE) study is a prospective observational trial designed to examine the occurrence of nonvertebral fragility fractures in a large, diverse patient population treated with teriparatide. The occurrence of clinical vertebral fractures and back pain will also be examined, as will bone mineral density, bone mineral content, bone area, safety and tolerability. Subjects will be followed through a course of teriparatide therapy for up to 24 months and for an additional 24 months after cessation of treatment. Therefore, subjects may participate in this study for up to 48 months. DANCE will provide data on the effectiveness and tolerability of teriparatide therapy in clinical practice that will complement the results of published controlled clinical trials.