Evidence map›Paper›PMID 31233639›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2019

Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment.

Pascale Chavassieux, Roland Chapurlat, Nathalie Portero-Muzy, Jean-Paul Roux, Pedro Garcia, Jacques P Brown, Cesar Libanati, Rogely W Boyce, Andrea Wang, Andreas Grauer

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2019. 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 102 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 6 pooled it
15.7field-weighted citation impact, top 1% 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

102 citing papers in PubMed, 6 syntheses or guidelines pooled it, 161 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Clinical Data for Parametrization ofFrontiers in bioengineering and biotechnology · 2022
    Pooled it
  7. Trial
  8. 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
  9. Trial
  10. Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women With Osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021
    Trial
  11. Trial
  12. Review
  13. Review
  14. Effects of romosozumab on the peripheral and axial skeleton in postmenopausal women at high fracture risk: real-world evidence from DXA and HR-pQCT data.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
  15. Article
  16. Mechanisms underlying the waning of osteoanabolic therapy effects in osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Review
  17. Article
  18. Article
  19. Review
  20. Article

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

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

10 authors at 5 institutions in 5 countries.

Pascale ChavassieuxINSERM UMR 1033, Université de Lyon, Lyon, France.ORCID 0000-0001-5128-7361
Roland ChapurlatINSERM UMR 1033, Université de Lyon, Lyon, France.ORCID 0000-0001-8214-6385
Nathalie Portero-MuzyINSERM UMR 1033, Université de Lyon, Lyon, France.
Jean-Paul RouxINSERM UMR 1033, Université de Lyon, Lyon, France.
Pedro GarciaEndocrinology Service, Osteoporosis Center, University Hospital of Monterrey, Monterrey, Mexico.
Jacques P BrownCHU de Quebec Research Centre and Department of Medicine, Laval University, Quebec, Canada.
Cesar LibanatiUCB Pharma, Brussels, Belgium.ORCID 0000-0003-1427-7839
Rogely W BoyceAmgen Inc, Thousand Oaks, CA, USA.
Andrea WangAmgen Inc, Thousand Oaks, CA, USA.
Andreas GrauerAmgen Inc, Thousand Oaks, CA, USA.
Université Claude Bernard Lyon 1 · FRAmgen (United States) · USCentre hospitalier de l'Université Laval · CAUCB Pharma (Belgium) · BEUniversity of Monterrey · MX

Funding

AmgenAstellasUCB Pharma
6 · The paper itself

Abstract

Sclerostin, a protein produced by osteocytes, inhibits bone formation. Administration of sclerostin antibody results in increased bone formation in multiple animal models. Romosozumab, a humanized sclerostin antibody, has a dual effect on bone, transiently increasing serum biochemical markers of bone formation and decreasing serum markers of bone resorption, leading to increased BMD and reduction in fracture risk in humans. We aimed to evaluate the effects of romosozumab on bone tissue. In a subset of 107 postmenopausal women with osteoporosis in the multicenter, international, randomized, double-blind, placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME), transiliac bone biopsies were performed either after 2 (n = 34) or 12 (n = 73) months of treatment with 210 mg once monthly of romosozumab or placebo to evaluate histomorphometry and microcomputed tomography-based microarchitectural endpoints. After 2 months, compared with either baseline values assessed after a quadruple fluorochrome labeling or placebo, significant increases (P < 0.05 to P < 0.001) in dynamic parameters of formation (median MS/BS: romosozumab 1.51% and 5.64%; placebo 1.60% and 2.31% at baseline and month 2, respectively) were associated with a significant decrease compared with placebo in parameters of resorption in cancellous (median ES/BS: placebo 3.4%, romosozumab 1.8%; P = 0.022) and endocortical (median ES/BS: placebo 6.3%, romosozumab 1.6%; P = 0.003) bone. At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006). No significant change was observed in periosteal and endocortical bone. This resulted in an increase in bone mass and trabecular thickness with improved trabecular connectivity, without significant modification of cortical porosity at month 12. In conclusion, romosozumab produced an early and transient increase in bone formation, but a persistent decrease in bone resorption. Antiresorptive action eventually resulted in decreased bone turnover. This effect resulted in significant increases in bone mass and improved microarchitecture. © 2019 American Society for Bone and Mineral Research.

Indexed as

OsteogenesisX-Ray MicrotomographyAgedAntibodies, MonoclonalBiopsyBone and BonesBone Density Conservation AgentsBone ResorptionFemaleHumansOsteoporosis, PostmenopausalAntibodies, MonoclonalBone Density Conservation AgentsromosozumabBONE HISTOMORPHOMETRYBONE MODELINGBONE REMODELINGMICROCOMPUTED TOMOGRAPHYOSTEOPOROSIS

Identifiers

PMID31233639
PMCPMC7027577
OpenAlexW2955498242

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.