Evidence map›Paper›PMID 34738660›Full record

ArticleJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2022

Romosozumab Enhances Vertebral Bone Structure in Women With Low Bone Density.

Kenneth Es Poole, Graham M Treece, Rose A Pearson, Andrew H Gee, Michael A Bolognese, Jacques P Brown, Stefan Goemaere, Andreas Grauer, David A Hanley, Carlos Mautalen and 5 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00896532 (A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

NCT00896532 phase2completednot on this map

A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

TypeinterventionalSponsorAmgenRan2009 to 2016Enrolled419ConditionsLow Bone Mineral Density, Postmenopausal OsteoporosisArmsPlacebo to Romosozumab, Alendronate, Teriparatide, Romosozumab, Denosumab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 28 citations in OpenAlex.

  1. 3D-modeling from hip DXA shows improved bone structure with romosozumab followed by denosumab or alendronate.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024
    Trial
  2. Article
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  6. Review
  7. Article
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  13. Anti-sclerostin antibodies: a new frontier in fragility fractures treatment.Therapeutic advances in musculoskeletal disease · 2023
    Review
  14. Metabolic Bone Diseases-A Topic of Great Diversity.Journal of clinical medicine · 2022
    Article
  15. Romosozumab and antiresorptive treatment: the importance of treatment sequence.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Article
  16. 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

15 authors at 9 institutions in 6 countries.

Kenneth Es PooleDepartment of Medicine, University of Cambridge and Addenbrooke's Hospital, Cambridge, UK.ORCID 0000-0003-4546-7352
Graham M TreeceDepartment of Engineering, University of Cambridge, Cambridge, UK.
Rose A PearsonDepartment of Engineering, University of Cambridge, Cambridge, UK.
Andrew H GeeDepartment of Engineering, University of Cambridge, Cambridge, UK.
Michael A BologneseBethesda Health Research Center, Bethesda, MD, USA.ORCID 0000-0002-7102-5518
Jacques P BrownCHU de Québec Research Centre and Laval University, Quebec City, Canada.
Stefan GoemaereGhent University Hospital, Ghent, Belgium.
Andreas GrauerAmgen Inc., Thousand Oaks, CA, USA.
David A HanleyUniversity of Calgary, Calgary, Canada.
Carlos MautalenCentro de Osteopatias Medicas, Buenos Aires, Argentina.
Chris RecknorUnited Osteoporosis Centers, Gainesville, GA, USA.
Yu-Ching YangAmgen Inc., Thousand Oaks, CA, USA.
Maria RojeskiAmgen Inc., Thousand Oaks, CA, USA.
Cesar LibanatiUCB Pharma, Brussels, Belgium.ORCID 0000-0003-1427-7839
Tristan WhitmarshInstitute of Astronomy, University of Cambridge, Cambridge, UK.ORCID 0000-0001-8272-9505
University of Cambridge · GBAmgen (United States) · USBone Health and Osteoporosis Foundation · USGhent University Hospital · BEHemanext (United States) · USUCB Pharma (Belgium) · BEUniversidad de Ciencias Medicas · CRUniversité Laval · CAUniversity of Calgary · CA

Funding

Department of HealthVersus Arthritis 20109
6 · The paper itself

Abstract

Romosozumab monoclonal antibody treatment works by binding sclerostin and causing rapid stimulation of bone formation while decreasing bone resorption. The location and local magnitude of vertebral bone accrual by romosozumab and how it compares to teriparatide remains to be investigated. Here we analyzed the data from a study collecting lumbar computed tomography (CT) spine scans at enrollment and 12 months post-treatment with romosozumab (210 mg sc monthly, n = 17), open-label daily teriparatide (20 μg sc, n = 19), or placebo (sc monthly, n = 20). For each of the 56 women, cortical thickness (Ct.Th), endocortical thickness (Ec.Th), cortical bone mineral density (Ct.bone mineral density (BMD)), cancellous BMD (Cn.BMD), and cortical mass surface density (CMSD) were measured across the first lumbar vertebral surface. In addition, color maps of the changes in the lumbar vertebrae structure were statistically analyzed and then visualized on the bone surface. At 12 months, romosozumab improved all parameters significantly over placebo and resulted in a mean vertebral Ct.Th increase of 10.3% versus 4.3% for teriparatide, an Ec.Th increase of 137.6% versus 47.5% for teriparatide, a Ct.BMD increase of 2.1% versus a -0.1% decrease for teriparatide, and a CMSD increase of 12.4% versus 3.8% for teriparatide. For all these measurements, the differences between romosozumab and teriparatide were statistically significant (p < 0.05). There was no significant difference between the romosozumab-associated Cn.BMD gains of 22.2% versus 18.1% for teriparatide, but both were significantly greater compared with the change in the placebo group (-4.6%, p < 0.05). Cortical maps showed the topographical locations of the increase in bone in fracture-prone areas of the vertebral shell, walls, and endplates. This study confirms widespread vertebral bone accrual with romosozumab or teriparatide treatment and provides new insights into how the rapid prevention of vertebral fractures is achieved in women with osteoporosis using these anabolic agents. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalAntibodies, MonoclonalBone DensityFemaleHumansLumbar VertebraeTeriparatideAntibodies, MonoclonalBone Density Conservation AgentsromosozumabTeriparatideANABOLICSANALYSIS/QUANTITATION OF BONEANTIRESORPTIVESBONE QCT/microCTDISEASES AND DISORDERS OF/RELATED TO BONEOSTEOPOROSISTHERAPEUTICS

Identifiers

PMID34738660
PMCPMC9299688
OpenAlexW3207812367

What OpenQuestion holds

Textmetadata
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.