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24.05.2017 | Original Article

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study

verfasst von: N. C. Wright, P. J. Foster, A. S. Mudano, J. A. Melnick, M. E. Lewiecki, W. J. Shergy, J. R. Curtis, G. R. Cutter, M. I. Danila, M. L. Kilgore, E. C. Lewis, S. L. Morgan, D. T. Redden, A. H. Warriner, K. G. Saag

Erschienen in: Osteoporosis International | Ausgabe 8/2017

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Abstract

Summary

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.

Introduction

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.

Methods

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.

Results

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.

Conclusions

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.

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Titel: Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study
verfasst von: N. C. Wright
P. J. Foster
A. S. Mudano
J. A. Melnick
M. E. Lewiecki
W. J. Shergy
J. R. Curtis
G. R. Cutter
M. I. Danila
M. L. Kilgore
E. C. Lewis
S. L. Morgan
D. T. Redden
A. H. Warriner
K. G. Saag
Publikationsdatum: 24.05.2017
Verlag: Springer London
Erschienen in: Osteoporosis International / Ausgabe 8/2017
Print ISSN: 0937-941X
Elektronische ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-017-4073-5

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