Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA.
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
Osteoporos Int. 2017 Aug;28(8):2495-2503. doi: 10.1007/s00198-017-4073-5. Epub 2017 May 24.
The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow.
The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question.
We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization.
Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study.
Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.
EDG 研究是一项旨在指导“药物假期”临床决策的计划性实用临床试验。本研究评估了该研究的工作流程和可行性。虽然参与者招募和治疗依从性不理想，但行政程序通常是可行的，对诊所流程的干扰最小。
长期使用阿仑膦酸钠（ALN）的利弊尚不清楚。一项大型实用 ALN 停药研究有可能回答这个问题。
我们对目前正在使用长期 ALN 的患者（年龄≥65 岁且使用 ALN 治疗≥3 年的女性）进行了为期 6 个月的 EDG 研究的试点研究，以确定研究工作流程和可行性，包括评估试验管理方面（例如，合同签订时间、机构审查委员会（IRB）批准），评估站点和参与者招募率，并评估随机分组后的结果，包括依从性、双膦酸盐相关不良事件以及参与者和站点满意度。我们在随机分组后 1 和 6 个月评估了结果。
有 9 个站点参与，包括 7 个社区医疗实践和 2 个学术医疗中心。平均（SD）而言，合同执行需要 3.4（2.3）个月，IRB 批准需要 13.9（4.1）天。各站点招募了 27 名参与者（13 名继续服用 ALN，14 名停止服用 ALN）。随访期间，22%的参与者未遵守随机分组：继续组为 30.8%，停药组为 14.3%。无骨折或不良事件报告。各站点报告称，工作流程没有问题，参与者对研究非常满意。
EDG 研究的行政程序通常是可行的，对诊所流程的干扰最小。在这个便利样本中，大多数实践站点的参与者招募都不理想。考虑到治疗组依从性较低，需要采取全面的招募方法才能有效实现 EDG 研究的科学目标。
