Evidence map›Paper›PMID 32047951›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 USA2020

Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study.

E M C Lau, R Dinavahi, Y C Woo, C-H Wu, J Guan, J Maddox, C Tolman, W Yang, C S Shin

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01631214 (A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis), which is not on this map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 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.

NCT01631214 phase3completednot on this map

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

TypeinterventionalSponsorAmgenRan2012 to 2017Enrolled4,093ConditionsPostmenopausal Women With OsteoporosisArmsRomosozumab, Alendronate, Placebo to Romosozumab, Placebo to Alendronate
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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  4. Association between bisphosphonate use and stroke risk: a meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Pooled it
  5. Pooled it
  6. Trial
  7. Article
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  9. Review
  10. Romosozumab in osteoporosis: yesterday, today and tomorrow.Journal of translational medicine · 2023
    Review
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  14. Early clinical effects, safety, and appropriate selection of bone markers in romosozumab treatment for osteoporosis patients: a 6-month study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  15. Review
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  20. Vertebral fracture is associated with myocardial infarction in incident hemodialysis patients: a Korean nationwide population-based study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
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

9 authors at 5 institutions in 6 countries.

E M C LauHong Kong Orthopaedic and Osteoporosis Center for Treatment and Research, 6th Floor, Tower 2, New World Tower, 18 Queen's Road Central, Hong Kong, Hong Kong. edith.lau@hkosc.org.
R DinavahiAmgen, Inc., Thousand Oaks, CA, USA.
Y C WooDepartment of Medicine, University of Hong Kong, Queen Mary Hospital, 102 Pok Fu Lam Road, Pok Fu Lam, Hong Kong.
C-H WuDepartment of Family Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Sheng Li Road, Tainan, Taiwan.
J GuanUCB Pharma, Brussels, Belgium.
J MaddoxAmgen, Inc., Thousand Oaks, CA, USA.
C TolmanAmgen Asia Holding Ltd, One Island East, 18 Westlands Rd, Quarry Bay, Hong Kong.
W YangAmgen, Inc., Thousand Oaks, CA, USA.
C S ShinDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Amgen (United States) · USNational Cheng Kung University Hospital · TWSeoul National University · KRUCB Pharma (Belgium) · BEUniversity of Hong Kong · HK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Romosozumab, a sclerostin antibody, exerts dual effect to increase bone formation and decrease bone resorption. Among high-risk postmenopausal East Asian women, romosozumab followed by alendronate was associated with lower incidences of fractures vs alendronate alone. Romosozumab demonstrates potential to address an unmet need in osteoporosis management in Asia.

introductionRomosozumab, a sclerostin antibody, exerts dual effect to increase bone formation and decrease bone resorption. The global ARCH study demonstrated superiority of romosozumab followed by alendronate in reducing fracture risk in high-risk postmenopausal osteoporotic women vs alendronate alone. We report outcomes among ARCH East Asian patients.

methodsIn ARCH, 4093 postmenopausal osteoporotic women with fragility fracture were randomized 1:1 to monthly romosozumab 210 mg or weekly alendronate 70 mg for 12 months, both followed by open-label alendronate. Primary endpoints were incidence of new vertebral fracture (VF) at 24 months and clinical fracture at primary analysis (confirmed fractures in ≥ 330 patients and all patients had opportunity to attend month 24 visit). This post hoc analysis was not powered to detect fracture-rate differences.

resultsThis analysis included 275 patients from Hong Kong, Korea, and Taiwan. Romosozumab followed by alendronate reduced risk of new VFs at 24 months by 60% (P = 0.11) and clinical fractures at primary analysis by 44% (P = 0.15) vs alendronate alone. Romosozumab followed by alendronate significantly increased mean bone mineral density at 24 months from baseline by a further 9.0%, 3.3%, and 3.0% at the lumbar spine, total hip, and femoral neck vs alendronate alone. Adverse event (AE) rates, including positively adjudicated serious cardiovascular AEs (1.6% vs 1.4% at 12 months for romosozumab vs alendronate), were similar across treatment groups.

conclusionsConsistent with the global analysis, romosozumab followed by alendronate was associated with lower incidences of new vertebral, clinical, non-vertebral, and hip fractures vs alendronate alone among East Asian patients.

Indexed as

AlendronateOsteoporosis, PostmenopausalAgedAntibodies, MonoclonalBone DensityBone Density Conservation AgentsFemaleFractures, BoneHong KongHumansRepublic of KoreaTaiwanAlendronateAntibodies, MonoclonalBone Density Conservation AgentsromosozumabAsiaFragility fractureImminent riskOsteoporosisRomosozumabTreatment

Identifiers

PMID32047951
PMCPMC7075830
OpenAlexW3006129495

What OpenQuestion holds

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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.