Evidence map›Paper›PMID 34167594›Full record

ArticlePilot and feasibility studies2021

Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.

Ioana R Marian, Megan Goff, Jennifer A E Williams, Malvika Gulati, Mae Chester-Jones, Anne Francis, Marion Watson, Tonia L Vincent, Sue Woollacott, Charles Mackworth-Young and 9 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04036929 (Hand Osteoarthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 49% 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.

NCT04036929 nacompletednot on this map

Hand Osteoarthritis: Investigating Pain Effects in a Randomised Placebo-controlled Feasibility Study of an Estrogen-containing Therapy

TypeinterventionalSponsorUniversity of OxfordRan2019 to 2021Enrolled28ConditionsHand OsteoarthritisArmsEstrogen-bazedoxifene, Placebo oral tablet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 1 country.

Ioana R MarianOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LD, UK. ioana.marian@csm.ox.ac.uk.ORCID http://orcid.org/0000-0002-0692-8112
Megan GoffCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Jennifer A E WilliamsCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Malvika GulatiCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Mae Chester-JonesOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LD, UK.
Anne FrancisOxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS) University of Oxford, Oxford, OX3 7LD, UK.
Marion WatsonOxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS) University of Oxford, Oxford, OX3 7LD, UK.
Tonia L VincentCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Sue WoollacottCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Charles Mackworth-YoungRheumatology Department, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
Victoria GloverWhite Horse Medical Practice, Faringdon Medical Centre, Oxfordshire, UK.
Dominic FurnissCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Matthew GardinerCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Sarah E LambCentre for Rehabilitation Research, NDORMS, University of Oxford, Oxford, UK.
Katy VincentNuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.
Vicki S BarberOxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS) University of Oxford, Oxford, OX3 7LD, UK.
Joanna BlackOxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS) University of Oxford, Oxford, OX3 7LD, UK.
Susan J DuttonOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LD, UK.
Fiona E WattCentre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, NDORMS, University of Oxford, Oxford, UK.
Nuffield Orthopaedic Centre · GBImperial College Healthcare NHS Trust · GBUniversity of Oxford · GBChurchill Hospital · GBHorse Hospital · GBUniversity of Exeter · GBWexham Park Hospital · GB

Funding

Medical Research Council MR/S016538/1Medical Research Council MR/S016538/2National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme PB-PG-0416-20023Versus Arthritis 21604
6 · The paper itself

Abstract

backgroundHand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design.

methodsThis is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60-90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study. DISCUSSION: Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference.

trial registrationISRCTN12196200 registered on 15 January 2019.

Indexed as

Clinical trialEstrogenFeasibilityHand osteoarthritisHormone replacement therapy

Identifiers

PMID34167594
PMCPMC8223359
OpenAlexW3173939969

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.