Evidence map›Paper›PMID 31036625›Full record

Trial reportAnnals of the rheumatic diseases2019

Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial.

Tsutomu Takeuchi, Yoshiya Tanaka, Satoshi Soen, Hisashi Yamanaka, Toshiyuki Yoneda, Sakae Tanaka, Takaya Nitta, Naoki Okubo, Harry K Genant, Désirée van der Heijde

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05372224 (Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure), which is not on this map. Cited by 79 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 8 pooled it
16.2field-weighted citation impact, top 1% 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.

NCT05372224 nacompletednot on this mapstarted 2020, after this paper: background citation

Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure

TypeinterventionalSponsorHospital Regional 1o de OctubreRan2020 to 2021Enrolled55ConditionsHypovitaminosis D, Osteoporosis, Postmenopausal, MenopauseArmsCholecalciferol
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 8 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
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  7. Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Pooled it
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  20. Pathogenic Role of Cytokines in Rheumatoid Arthritis.Journal of clinical medicine · 2025
    Review

19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 10 institutions in 7 countries.

Tsutomu Takeuchi *Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan tsutake@z5.keio.jp.ORCID 0000-0003-1111-8218
Yoshiya Tanaka *First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Satoshi SoenDepartment of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan.
Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Toshiyuki YonedaDepartment of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan.
Sakae TanakaDepartment of Orthopedic Surgery, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Takaya NittaClinical Development Department, Daiichi Sankyo Co., Ltd, Shinagawa-ku, Tokyo, Japan.
Naoki OkuboBiostatistics & Data Management Department, Daiichi Sankyo Co., Ltd, Shinagawa-ku, Tokyo, Japan.
Harry K GenantDepartment of Radiology, Medicine and Orthopedic Surgery, University of California, San Francisco, California, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
Daiichi Sankyo (Germany) · DEDaiichi Sankyo (United Kingdom) · GBInstitute of Rheumatology · CZKeio University · JPLeiden University Medical Center · NLNara Medical University Hospital · JPThe University of Osaka · JPThe University of Tokyo · JPUniversity of California, San Francisco · USUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of denosumab in suppressing joint destruction when added to conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy in patients with rheumatoid arthritis (RA).

methodsThis was a multi-centre, randomised, double-blind, parallel-group, placebo-controlled phase 3 study in Japan. Patients with RA aged ≥20 years receiving csDMARDs were randomly assigned (1:1:1) to denosumab 60 mg every 3 months (Q3M), denosumab 60 mg every 6 months (Q6M) or placebo. The change in the modified total Sharp score (mTSS) and effect on bone mineral density (BMD) at 12 months was evaluated.

resultsIn total, 654 patients received the trial drugs. Denosumab groups showed significantly less progression of joint destruction. The mean changes in the mTSS at 12 months were 1.49 (95% CI 0.99 to 1.99) in the placebo group, 0.99 (95% CI 0.49 to 1.49) in the Q6M group (p=0.0235) and 0.72 (95% CI 0.41 to 1.03) in the Q3M group (p=0.0055). The mean changes in bone erosion score were 0.98 (95% CI 0.65 to 1.31) in the placebo group, 0.51 (95% CI 0.22 to 0.80) in the Q6M group (p=0.0104) and 0.22 (95% CI 0.09 to 0.34) in the Q3M group (p=0.0001). No significant between-group difference was observed in the joint space narrowing score. The per cent change in lumbar spine (L1-L4) BMD in the placebo, Q6M and Q3M groups were -1.03%, 3.99% (p<0.0001) and 4.88% (p<0.0001). No major differences were observed among safety profiles.

conclusionsDenosumab inhibits the progression of joint destruction, increases BMD and is well tolerated in patients with RA taking csDMARD.

Indexed as

Absorptiometry, PhotonAdultAgedAntirheumatic AgentsArthritis, RheumatoidBone DensityDenosumabDisease ProgressionDouble-Blind MethodFemaleHumansLumbar VertebraeMaleMiddle AgedRANK LigandTreatment OutcomeAntirheumatic AgentsDenosumabRANK LigandTNFSF11 protein, humandenosumaberosionjoint destructionrheumatoid arthritis

Identifiers

PMID31036625
PMCPMC6585575
OpenAlexW2943342119

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.