Evidence map›Paper›PMID 29694685›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2018

Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study.

Michael R McClung, Jacques P Brown, Adolfo Diez-Perez, Heinrich Resch, John Caminis, Paul Meisner, Michael A Bolognese, Stefan Goemaere, Henry G Bone, Jose R Zanchetta and 3 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 131 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 18 pooled it
–field-weighted citation impact
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
NCT05101018 phase4active not recruitingnot on this mapstarted 2021, after this paper: background citation

Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

TypeinterventionalSponsorJames J. Peters Veterans Affairs Medical CenterRan2021 to 2027Enrolled40ConditionsOsteoporosis, Spinal Cord InjuriesArmsRomosozumab, Denosumab
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 18 syntheses or guidelines pooled it.

  1. A systematic review and meta-analysis of sequential treatment strategies for 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
    Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation · 2025
    Pooled it
  6. Pooled it
  7. Guideline
  8. Pooled it
  9. Guideline
  10. Clinical practice guideline for management of osteoporosis and fracture prevention in Canada: 2023 update.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2023
    Guideline
  11. Guideline
  12. Pooled it
  13. Guideline
  14. A systematic review and meta-analysis of efficacy and safety of Romosozumab in 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 · 2022
    Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Osteoporosis Management in the Era of COVID-19.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2020
    Guideline
  19. Trial
  20. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025
    Trial

71 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Michael R McClungOregon Osteoporosis Center, Portland, OR, USA.
Jacques P BrownLaval University and CHU de Québec Research Centre, Quebec City, QC, Canada.
Adolfo Diez-PerezMedicine Hospital del Mar/IMIM, Autonomous University of Barcelona, Barcelona, Spain.
Heinrich ReschSt Vincent Hospital, Vienna, Austria.
John CaminisUCB Pharma, Brussels, Belgium.
Paul MeisnerUCB Pharma, Brussels, Belgium.
Michael A BologneseBethesda Health Research Center, Bethesda, MD, USA.
Stefan GoemaereGhent University Hospital, Gent, Belgium.
Henry G BoneMichigan Bone and Mineral Clinic, Detroit, MI, USA.
Jose R ZanchettaInstituto de Investigaciones Metabólicas, Buenos Aires, Argentina.
Judy MaddoxAmgen Inc., Thousand Oaks, CA, USA.
Sarah BrayAmgen Ltd., Cambridge, UK.
Andreas GrauerAmgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Over 12 months, romosozumab increased bone formation and decreased bone resorption, resulting in increased bone mineral density (BMD) in postmenopausal women with low BMD (NCT00896532). Herein, we report the study extension evaluating 24 months of treatment with romosozumab, discontinuation of romosozumab, alendronate followed by romosozumab, and romosozumab followed by denosumab. Postmenopausal women aged 55 to 85 years with a lumbar spine (LS), total hip (TH), or femoral neck T-score ≤-2.0 and ≥-3.5 were enrolled and randomly assigned to placebo, one of five romosozumab regimens (70 mg, 140 mg, 210 mg monthly [QM]; 140 mg Q3M; 210 mg Q3M) for 24 months, or open-label alendronate for 12 months followed by romosozumab 140 mg QM for 12 months. Eligible participants were then rerandomized 1:1 within original treatment groups to placebo or denosumab 60 mg Q6M for an additional 12 months. Percentage change from baseline in BMD and bone turnover markers (BTMs) at months 24 and 36 and safety were evaluated. Of 364 participants initially randomized to romosozumab, placebo, or alendronate, 315 completed 24 months of treatment and 248 completed the extension. Romosozumab markedly increased LS and TH BMD through month 24, with largest gains observed with romosozumab 210 mg QM (LS = 15.1%; TH = 5.4%). Women receiving romosozumab who transitioned to denosumab continued to accrue BMD, whereas BMD returned toward pretreatment levels with placebo. With romosozumab 210 mg QM, bone formation marker P1NP initially increased after treatment initiation and gradually decreased to below baseline by month 12, remaining below baseline through month 24; bone resorption marker β-CTX rapidly decreased after treatment, remaining below baseline through month 24. Transition to denosumab further decreased both BTMs, whereas after transition to placebo, P1NP returned to baseline and β-CTX increased above baseline. Adverse events were balanced between treatment groups through month 36. These data suggest that treatment effects of romosozumab are reversible upon discontinuation and further augmented by denosumab. © 2018 The Authors Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.

Indexed as

AgedAntibodies, MonoclonalBiomarkersBone and BonesBone DensityBone RemodelingDenosumabDouble-Blind MethodDrug Administration ScheduleFemaleHumansMiddle AgedPlacebosPostmenopauseTime FactorsTreatment OutcomeAntibodies, MonoclonalBiomarkersDenosumabPlacebosromosozumabBONE MINERAL DENSITYDENOSUMABPOSTMENOPAUSAL OSTEOPOROSISROMOSOZUMAB

Identifiers

PMID29694685

What OpenQuestion holds

Textmetadata
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.