Evidence map›Paper›PMID 35639174›Full record

Trial reportJournal of bone and mineral metabolism2022

Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease.

Akimitsu Miyauchi, Etsuro Hamaya, Kiyoshi Nishi, Cae Tolman, Junichiro Shimauchi

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Journal of bone and mineral metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01575834 (A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT01575834 phase3completednot on this map

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

TypeinterventionalSponsorAmgenRan2012 to 2016Enrolled7,180ConditionsPostmenopausal OsteoporosisArmsRomosozumab, Placebo, Denosumab
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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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

5 authors at 1 institution in 1 country.

Akimitsu MiyauchiMiyauchi Medical Center, Osaka, Japan.
Etsuro HamayaAmgen K.K., Midtown Tower 9-7-1, Akasaka Minato-ku, Tokyo, 107-6239, Japan. ehamaya@amgen.com.
Kiyoshi NishiAmgen K.K., Midtown Tower 9-7-1, Akasaka Minato-ku, Tokyo, 107-6239, Japan.
Cae TolmanAmgen Asia, Hong Kong, China.
Junichiro ShimauchiAmgen K.K., Midtown Tower 9-7-1, Akasaka Minato-ku, Tokyo, 107-6239, Japan.
Acoustic Metamaterials Group (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis post hoc analysis of the placebo-controlled phase 3 FRAME study assessed the efficacy and safety of romosozumab in a subpopulation of Japanese postmenopausal women with osteoporosis and chronic kidney disease (CKD). MATERIALS AND

methodsData were analyzed by baseline estimated glomerular filtration rate (eGFR), where < 90 mL/min/1.73 m

resultsOf 489 Japanese patients with available eGFR data, 339 had mild-to-moderate CKD (romosozumab, n = 170; placebo, n = 169) and 150 had normal renal function (romosozumab, n = 75; placebo, n = 75). Compared with placebo, romosozumab increased lumbar spine BMD by 14.8% (95% confidence interval [CI] 13.7-15.9) and 15.2% (95% CI 13.4-16.9) in the eGFR < 90 and ≥ 90 mL/min/1.73 m

conclusionRomosozumab for 12 months is an effective and well-tolerated treatment option for Japanese patients with osteoporosis and mild-to-moderate CKD.

Indexed as

Antibodies, MonoclonalOsteoporosis, PostmenopausalRenal Insufficiency, ChronicBone DensityBone Density Conservation AgentsFemaleHumansJapanAntibodies, MonoclonalBone Density Conservation AgentsromosozumabChronic kidney diseaseJapanese patientsOsteoporosisRomosozumab

Identifiers

PMID35639174
OpenAlexW4282938495

What OpenQuestion holds

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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.