Evidence map›Paper›PMID 28540506›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017

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

N C Wright, P J Foster, A S Mudano, J A Melnick, E M Lewiecki, W J Shergy, J R Curtis, G R Cutter, M I Danila, M L Kilgore and 5 more

Erratum issuedOpen access · greenAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Atypical femur fractures: current understanding and approach to management.Therapeutic advances in musculoskeletal disease · 2020
    Review
  3. Medical Treatment for Osteoporosis: From Molecular to Clinical Opinions.International journal of molecular sciences · 2019
    Review
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

N C WrightDepartment of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA. ncwright@uab.edu.
P J FosterDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
A S MudanoDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
J A MelnickDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
E M LewieckiNew Mexico Clinical Research and Osteoporosis Center, Albuquerque, NM, USA.
W J ShergyRheumatology Associates of North Alabama, Huntsville, AL, USA.
J R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
G R CutterDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
M I DanilaDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
M L KilgoreDeparment of Health Care Organization and Policy, University of Alabama at Birmingham, Birmingham, AL, USA.
E C LewisDivision of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
S L MorganDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
D T ReddenDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
A H WarrinerDivision of Endocrinology, Diabetes and Metabolism, University of Alabama at Birmingham, Birmingham, AL, USA.
K G SaagDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
University of Alabama at Birmingham · USNew Mexico Clinical Research & Osteoporosis Center · USRheumatology Consultants · US

Funding

Genetic Architecture of Rheumatoid Arthritis in African-AmericansK23AR062100 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI DANILA, MARIA IOANA · 2012 to 2016
$674k
Pilot Studies for the Active Comparator Osteoporosis Large Simple Trial (ATLAST)R21AR062300 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, KENNETH G · 2012 to 2013
$372k
NIAMS NIH HHS K23 AR062100NIAMS NIH HHS R21 AR062300
6 · The paper itself

Abstract

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.

introductionThe 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.

methodsWe 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.

resultsNine 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.

conclusionsAdministrative 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.

Indexed as

AgedAged, 80 and overBone Density Conservation AgentsClinical Decision-MakingDiphosphonatesDrug Administration ScheduleDrug MonitoringFeasibility StudiesFemaleHumansOsteoporosis, PostmenopausalOsteoporotic FracturesPilot ProjectsWithholding TreatmentBone Density Conservation AgentsDiphosphonatesAlendronateDiscontinuationDrug holidayOsteoporosis

Identifiers

PMID28540506
PMCPMC5734645
OpenAlexW2617743756

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.