Evidence map›Paper›PMID 31393399›Full record

Trial reportMedicine2019

Efficacy of denosumab for restoring normal bone mineral density in women receiving adjuvant aromatase inhibitors for early breast cancer.

Koichi Sakaguchi, Hisako Ono, Katsuhiko Nakatsukasa, Takashi Ishikawa, Yoshie Hasegawa, Masato Takahashi, Naoki Niikura, Kei Koizumi, Teruhisa Sakurai, Hideo Shigematsu and 14 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03324932 (A Multicenter, Randomized, Comparative Study Regarding the Efficacy of Denosumab on Normal Bone Mineral Density in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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.

NCT03324932 phase3active not recruitingnot on this map

A Multicenter, Randomized, Comparative Study Regarding the Efficacy of Denosumab on Normal Bone Mineral Density in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer (ENDEAVOR Trial)

TypeinterventionalSponsorKyoto Prefectural University of MedicineRan2017 to 2027Enrolled160ConditionsBreast CancerArmsDenosumab Injection
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
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

24 authors at 12 institutions in 1 country.

Koichi SakaguchiDivision of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto.
Hisako OnoDivision of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto.
Katsuhiko NakatsukasaDepartment of Biostatistics, Graduate School of Medicine, Hokkaido University, Nakatsukasa Adachi Clinic, Japan.
Takashi IshikawaDepartment of Biostatistics, Kyoto Prefectural University of Medicine Graduate School of Medical Science.
Yoshie HasegawaDepartment of Radiology, Tokyo Medical University.
Masato TakahashiDepartment of Breast Surgical Oncology, Hirosaki Municipal Hospital.
Naoki NiikuraDepartment of Breast Surgery, Hokkaido Cancer Center.
Kei KoizumiDepartment of Breast and Endocrine Surgery, Tokai University School of Medicine.
Teruhisa SakuraiDepartment of Breast Surgery, Hamamatsu University School of Medicine.
Hideo ShigematsuDepartment of Surgery, Wakayama Medical University Kihoku Hospital.
Shunji TakahashiDepartment of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center.
Shinichiro TairaDepartment of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center.
Masato SuzukiDepartment of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research.
Kazutaka NaruiDepartment of Breast Surgery, National Hospital Organization Chiba Medical Center, Yokohama City University Medical Center.
Daishu MiuraDepartment of Breast and Thyroid Surgery, Yokohama City University Medical Center.
Kimito YamadaDepartment of Biostatistics, Kyoto Prefectural University of Medicine Graduate School of Medical Science.
Mana YoshimuraDepartment of Breast Oncology.
Hisashi ShioyaAkasaka Miura Clinic, Tokyo.
Eiichi KonishiDepartment of Surgical Pathology, Kyoto Prefectural University of Medicine.
Yokota IsaoDepartment of Surgery, The Jikei University School of Medicine.
Kojiro ImaiDepartment for Medical Innovation and Translational Medical Science.
Kei FujikawaKyoto Prefectural University of Medicine Graduate School of Medical Science.
Tetsuya TaguchiDivision of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto.
Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society
Kyoto Prefectural University of Medicine · JPKure Medical Center · JPHamamatsu University School of Medicine · JPHokkaido University Hospital · JPJapanese Foundation For Cancer Research · JPJikei University School of Medicine · JPNational Hospital Organization · JPOgaki Municipal Hospital · JPTokai University · JPTokyo Medical University · JPWakayama Medical University · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteoporosis is a major side effect of aromatase inhibitors (AIs), which are greatly effective in the treatment of breast cancer. However, there are no satisfactory measures against osteoporosis. In this multicenter, randomized, comparative study, we evaluate the efficacy of denosumab for preventing loss of bone mineral density (BMD) induced by adjuvant therapy with AI s in breast cancer patients with normal BMD. PATIENTS AND

methodsThe bone loss-suppressing effect of denosumab will be comparatively evaluated in postmenopausal patients scheduled to receive letrozole or anastrozole as a postoperative endocrine therapy for stage I-IIIA hormone-sensitive breast cancer and a control group. Patients will be administered letrozole 2.5 mg or anastrozole 1 mg once a day, and the treatment will be continued for 5 years unless recurrence, secondary cancer, or unacceptable toxicity develops. Patients in the denosumab group will receive a subcutaneous injection of 60 mg of denosumab every 6 months. The primary endpoint is the rate of change in the lumbar spine (L1-L4) BMD, as determined by dual-energy X-ray absorptiometry (DXA), 12 months after the start of the injection. The secondary endpoints were ETHICS AND DISSEMINATION:: The protocol was approved by the institutional review boards of Kyoto Prefectural University of Medicine and all the participating faculties. Written informed consent was obtained from all patients before registration, in accordance with the Declaration of Helsinki. Results of the study will be disseminated via publications in peer-reviewed journals.

trial registrationClinical Trials.gov Identifier: NCT03324932, Japan Registry of Clinical Trial (jRCT): CRB5180001.

Indexed as

AdultAromatase InhibitorsBiomarkersBone and BonesBone DensityBreast NeoplasmsDenosumabDisease-Free SurvivalFemaleFractures, BoneHumansMiddle AgedNeoplasm StagingOsteoporosisResearch DesignAromatase InhibitorsBiomarkersDenosumab

Identifiers

PMID31393399
PMCPMC6708609
OpenAlexW2969054480

What OpenQuestion holds

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LicenceCC BY
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.