Evidence map›Paper›PMID 23794225›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2014

Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab.

Tony M Keaveny, Michael R McClung, Harry K Genant, Jose R Zanchetta, David Kendler, Jacques P Brown, Stefan Goemaere, Chris Recknor, Maria L Brandi, Richard Eastell and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized 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, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00089791 (A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM), which is not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
10.6field-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.

NCT00089791 phase3completednot on this map

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

TypeinterventionalSponsorAmgenRan2004 to 2008Enrolled7,808ConditionsOsteoporosisArmsplacebo, Denosumab
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 114 citations in OpenAlex.

  1. Denosumab significantly increases bone mineral density and reduces bone turnover compared with monthly oral ibandronate and risedronate in postmenopausal women who remained at higher risk for fracture despite previous suboptimal treatment with an oral bisphosphonate.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2014
    Pooled it
  2. 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
  3. Trial
  4. Effect of Denosumab Compared With Risedronate on Bone Strength in Patients Initiating or Continuing Glucocorticoid Treatment.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Trial
  5. Trial
  6. Trial
  7. Effect of denosumab on trabecular bone score in postmenopausal women with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017
    Trial
  8. Trial
  9. The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Trial
  10. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2012
    Trial
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Relative Effects of Radiation-Induced Changes in Bone Mass, Structure, and Tissue Material on Vertebral Strength in a Rat Model.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
    Article
  19. Review
  20. 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

15 authors at 13 institutions in 8 countries.

Tony M KeavenyUniversity of California Berkeley, Berkeley, CA, USA; O.N. Diagnostics, Berkeley, CA, USA.
Michael R McClung
Harry K Genant
Jose R Zanchetta
David Kendler
Jacques P Brown
Stefan Goemaere
Chris Recknor
Maria L Brandi
Richard Eastell
David L Kopperdahl
Klaus Engelke
Thomas Fuerst
Hoi-Shen Radcliffe
Cesar Libanati
Bone Health and Osteoporosis Foundation · USO.N. Diagnostics (United States) · USAmgen (United Kingdom) · GBAmgen (United States) · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGhent University · BEInstituto de Diagnóstico e Investigaciones Metabólicas · ARQuebec Research and Development CentreSynlab Czech (Czechia) · CZUniversity of British Columbia · CAUniversity of California, Berkeley · USUniversity of Florence · ITUniversity of Sheffield · GB

Funding

Medical Research Council MR/K006312/1
6 · The paper itself

Abstract

In the randomized, placebo-controlled FREEDOM study of women aged 60 to 90 years with postmenopausal osteoporosis, treatment with denosumab once every 6 months for 36 months significantly reduced hip and new vertebral fracture risk by 40% and 68%, respectively. To gain further insight into this efficacy, we performed a nonlinear finite element analysis (FEA) of hip and spine quantitative computed tomography (QCT) scans to estimate hip and spine strength in a subset of FREEDOM subjects (n = 48 placebo; n = 51 denosumab) at baseline, 12, 24, and 36 months. We found that, compared with baseline, the finite element estimates of hip strength increased from 12 months (5.3%; p < 0.0001) and through 36 months (8.6%; p < 0.0001) in the denosumab group. For the placebo group, hip strength did not change at 12 months and decreased at 36 months (-5.6%; p < 0.0001). Similar changes were observed at the spine: strength increased by 18.2% at 36 months for the denosumab group (p < 0.0001) and decreased by -4.2% for the placebo group (p = 0.002). At 36 months, hip and spine strength increased for the denosumab group compared with the placebo group by 14.3% (p < 0.0001) and 22.4% (p < 0.0001), respectively. Further analysis of the finite element models indicated that strength associated with the trabecular bone was lost at the hip and spine in the placebo group, whereas strength associated with both the trabecular and cortical bone improved in the denosumab group. In conclusion, treatment with denosumab increased hip and spine strength as estimated by FEA of QCT scans compared with both baseline and placebo owing to positive treatment effects in both the trabecular and cortical bone compartments. These findings provide insight into the mechanism by which denosumab reduces fracture risk for postmenopausal women with osteoporosis.

Indexed as

Absorptiometry, PhotonAgedAntibodies, Monoclonal, HumanizedBiomechanical PhenomenaDenosumabFemaleFinite Element AnalysisHipHumansOsteoporosis, PostmenopausalPostmenopauseSpineTomography, X-Ray ComputedAntibodies, Monoclonal, HumanizedDenosumabDENOSUMABFINITE ELEMENT ANALYSISHIP STRENGTHOSTEOPOROSISSPINE STRENGTH

Identifiers

PMID23794225
PMCPMC4238810
OpenAlexW1808538080

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.