Evidence map›Paper›PMID 31420748›Full record

Trial reportJournal of bone and mineral metabolism2020

Phase II/III, randomized, double-blind, parallel-group study of monthly delayed-release versus daily immediate-release risedronate tablets in Japanese patients with involutional osteoporosis.

Satoshi Soen, Hideaki Kishimoto, Hiroshi Hagino, Teruki Sone, Hiroaki Ohishi, Tsukasa Fujimoto, Emma Sasaki, Sakae Tanaka, Toshitsugu Sugimoto

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
PubMed Publisher
In one paragraph

Trial report in Journal of bone and mineral metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

9 authors at 7 institutions in 1 country.

Satoshi SoenDepartment of Orthopedic Surgery and Rheumatology, Kindai University Nara Hospital, 1248-1 Otodacho, Ikoma, Nara, 630-0293, Japan. nra48207@nifty.com.
Hideaki KishimotoDepartment of Orthopedic Surgery, Nojima Hospital, Tottori, Japan.
Hiroshi HaginoSchool of Health Science and Rehabilitation Division, Tottori University, Yonago, Tottori, Japan.
Teruki SoneDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.
Hiroaki OhishiEA Pharma Co., Ltd., Chuo-ku, Tokyo, Japan.
Tsukasa FujimotoTakeda Pharmaceutical Company Ltd., Chuo-ku, Osaka, Japan.
Emma SasakiTakeda Pharmaceutical Company Ltd., Chuo-ku, Osaka, Japan.
Sakae TanakaOrthopedic Surgery, Sensory and Motor System Medicine, Surgical Sciences, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Toshitsugu SugimotoInternal Medicine 1, Shimane University, Faculty of Medicine, Izumo, Shimane, Japan.
Takeda (Japan) · JPEA Pharma (Japan) · JPKawasaki Medical School · JPKindai University · JPShimane University · JPThe University of Tokyo · JPTottori University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Absorption of oral immediate-release (IR) risedronate tablets is reduced by food intake, thus a delayed-release (DR) tablet has been developed to overcome the necessity of taking IR tablets under fasting conditions. This randomized, double-blind, phase II/III study compared efficacy and safety of risedronate IR once-daily (QD) and DR once-monthly (QM) tablets in Japanese patients with involutional osteoporosis. Patients received 2.5 mg IR on awakening QD, or 25 or 37.5 mg DR on awakening, following breakfast, or 30 min after breakfast, QM for 12 months. Primary endpoint was non-inferiority in mean percent change from baseline to end of study (month 12, last observation carried forward [M12, LOCF]) in mean lumbar spine (L

Indexed as

Asian PeopleAgedBiomarkersBone DensityBone Density Conservation AgentsBone RemodelingDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleOsteoporosisPatient ComplianceRisedronic AcidSpinal FracturesTreatment OutcomeBiomarkersBone Density Conservation AgentsRisedronic AcidDelayed releaseImmediate releaseJapanOsteoporosisRisedronate

Identifiers

PMID31420748
OpenAlexW2967540785

What OpenQuestion holds

Textmetadata
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.