Evidence map›Paper›PMID 33770201›Full record

Observational studyOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2021

Early clinical effects, safety, and predictors of the effects of romosozumab treatment in osteoporosis patients: one-year study.

A Tominaga, K Wada, K Okazaki, H Nishi, Y Terayama, Y Kato

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
5.3field-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

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation · 2025
    Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Clarifying the romosozumab "Super-Responder" phenotype: response to methodological concerns.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Article
  7. Article
  8. Article
  9. Romosozumab super-responders in clinical practice: insights from a large Italian multicenter cohort of women with severe postmenopausal osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Sequential and combination therapy with romosozumab.Journal of bone and mineral metabolism · 2025
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

A TominagaDepartment of Orthopedic Surgery, Tokyo Women's Medical University, 8-1 Kawadacho Shinjuku-ku, Tokyo, Japan.
K WadaDepartment of Orthopedic Surgery, Tokyo Women's Medical University, 8-1 Kawadacho Shinjuku-ku, Tokyo, Japan. keijiwadajp@yahoo.co.jp.
K OkazakiDepartment of Orthopedic Surgery, Tokyo Women's Medical University, 8-1 Kawadacho Shinjuku-ku, Tokyo, Japan.
H NishiHasuda Hospital, 1662-1 Negane Hasudashi, Saitama, Japan.
Y TerayamaHasuda Hospital, 1662-1 Negane Hasudashi, Saitama, Japan.
Y KatoKita Shinagawa 3rd Hospital, 3-3-7 Kitashinagawa Shinagawa-ku, Tokyo, Japan.
Tokyo Women's Medical University · JPTsuda University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Romosozumab is an effective treatment for spine osteoporosis because it reduces the incidence of new fractures and significantly increases the percent change in the spine BMD at 12 months. The percent change in the spine BMD is higher in patients not previously treated with other anti-osteoporosis medications.

introductionRomosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody, which increases bone formation and suppresses bone resorption. The aim of our study was to elucidate the clinical effects, safety, and predictors of the effects of one-year romosozumab treatment.

methodsThis study was an observational study designed as a pre-post study in 262 patients. Romosozumab (210 mg) was administered subcutaneously once every 4 weeks during 12 months. We focused on incidence of new fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers.

resultsThere were five cases of new fractures during one-year romosozumab treatment. There were no fatal adverse events. Percent changes from baseline in the spine and total hip BMD after 12 months of romosozumab treatment were 10.67% and 2.04%, respectively. Romosozumab had better effects in cases of severe osteoporosis with low spine BMD, high TRACP-5b, and high iP1NP at the start of romosozumab treatment. The percent change in the spine BMD at 12 months was significantly lower in the group transitioning from bisphosphonates than in the group not previously treated with other anti-osteoporosis medications.

conclusionRomosozumab is an effective treatment for spine osteoporosis because it significantly increases the percent change in the spine BMD at 12 months. The percent change in the spine BMD is higher in patients not previously treated with other anti-osteoporosis medications.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalAntibodies, MonoclonalBone DensityFemaleHumansAntibodies, MonoclonalBone Density Conservation AgentsromosozumabAnti-osteoporosis drugAnti-sclerostin antibodyBMDBone metabolism markersOsteoporosisRomosozumab

Identifiers

PMID33770201
PMCPMC7996128
OpenAlexW3138944102

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.