Evidence map›Paper›PMID 34324082›Full record

Observational studyJournal of bone and mineral metabolism2021

Efficacy of romosozumab in patients with osteoporosis on maintenance hemodialysis in Japan; an observational study.

Motohiko Sato, Masaaki Inaba, Shinsuke Yamada, Masanori Emoto, Yoshiteru Ohno, Yoshihiro Tsujimoto

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of bone and mineral metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 3% 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

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
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  3. Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation · 2025
    Pooled it
  4. Review
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  6. Bone turnover markers in the management of CKD-associated osteoporosis-a European consensus.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
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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

6 authors at 3 institutions in 1 country.

Motohiko SatoDepartment of Orthopedics, Inoue Hospital, Osaka, Japan.
Masaaki InabaRenal Center, Ohno Memorial Hospital, 1-26-10, Minami-Horie, Nishi-ku, Osaka, Osaka, 550-0015, Japan. m-inaba@ohno.or.jp.
Shinsuke YamadaDepartment of Metabolism, Endocrinology, and Molecular Medicine, Osaka City University Medical School, Osaka, Japan.
Masanori EmotoDepartment of Metabolism, Endocrinology, and Molecular Medicine, Osaka City University Medical School, Osaka, Japan.
Yoshiteru OhnoRenal Center, Ohno Memorial Hospital, 1-26-10, Minami-Horie, Nishi-ku, Osaka, Osaka, 550-0015, Japan.
Yoshihiro TsujimotoRenal Center, Inoue Hospital, Osaka, Japan.
Inoue Hospital · JPOsaka City University · JPOsaka Minami Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRomosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HD patients with a high risk of fracture. MATERIALS AND

methodsThis was a single-center 1-year study in Japanese HD patients. Among 96 HD romosozumab-treated HD patients with high risk of fracture, 76 HD patients completed 1 year of subcutaneous administration of romosozumab (210 mg/4 weeks) for 1 year. Romosozumab-untreated HD patients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored.

resultsDuring romosozumab treatment of 76 HD patients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1-4), and 7.2% ± 8.3% at the femoral neck at 1 year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4 weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4-48 weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HD patients and10.9% in romosozumab-untreated HD patients.

conclusionsBMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1 year in HD patients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1 year of study, suggesting romosozumab as a promising agent for HD patients with severe osteoporosis.

Indexed as

Bone Density Conservation AgentsOsteoporosisAntibodies, MonoclonalBone DensityHumansJapanRenal DialysisAntibodies, MonoclonalBone Density Conservation AgentsromosozumabBone mineral densityHemodialysisOsteoporosisRomosozumabTRACP-5b

Identifiers

PMID34324082
OpenAlexW3186615664

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.