Evidence map›Paper›PMID 33537844›Full record

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

Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study.

E V McCloskey, H Johansson, N C Harvey, M Lorentzon, Y Shi, J A Kanis

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report 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. 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 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Romosozumab efficacy and safety in European patients enrolled in the FRAME trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Trial
  3. Article
  4. Article
  5. Exploring the Role ofOrthopedic research and reviews · 2026
    Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. 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

6 authors at 5 institutions in 4 countries.

E V McCloskeyCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK. e.v.mccloskey@sheffield.ac.uk.ORCID http://orcid.org/0000-0003-0177-8140
H JohanssonCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
N C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
M LorentzonMary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.
Y ShiAmgen Inc, Thousand Oaks, CA, USA.
J A KanisCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
University Hospital Southampton NHS Foundation Trust · GBAmgen (United States) · USAustralian Catholic University · AUNorthern General Hospital · GBSahlgrenska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to determine the interaction between baseline FRAX

introductionPost hoc analyses of placebo-controlled osteoporosis treatment studies have shown significantly greater reductions of fracture incidence for higher fracture risk patients. This study determined the interaction between baseline FRAX

methodsUsing an ITT approach, an extension of Poisson regression analysis studied the relationship between treatment, FRAX

resultsCompared with placebo, romosozumab reduced the incidence of all fracture outcomes in the first year (range: 32% reduction in MOF [p = 0.07] to 80% reduction in clinical vertebral fractures [p = 0.038]). Significant interactions were observed between efficacy and baseline FRAX

conclusionsEfficacy of romosozumab on clinical fracture, osteoporotic fracture, and MOF is significantly greater in patients at high baseline fracture risk compared with placebo.

Indexed as

Bone Density Conservation AgentsOsteoporosis, PostmenopausalOsteoporotic FracturesAntibodies, MonoclonalBone DensityFemaleHumansRisk AssessmentRisk FactorsAntibodies, MonoclonalBone Density Conservation AgentsromosozumabFracture reductionFracture riskFRAXRomosozumab

Identifiers

PMID33537844
PMCPMC8376732
OpenAlexW3128462685

What OpenQuestion holds

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LicenceCC BY-NC
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.