Evidence map›Paper›PMID 18767928›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2009

Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial.

Jacques P Brown, Richard L Prince, Chad Deal, Robert R Recker, Douglas P Kiel, Luiz H de Gregorio, Peyman Hadji, Lorenz C Hofbauer, Jose M Alvaro-Gracia, Huei Wang and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative 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, 2009. 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 224 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
224citing papers in PubMed, 18 pooled it
24.8field-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.

NCT00330460 phase3completednot on this map

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty

TypeinterventionalSponsorAmgenRan2006 to 2008Enrolled1,189ConditionsOsteoporosis, OsteopeniaArmsAlendronate, Denosumab
NCT03293108 phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

A Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Non-inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety Between Arylia (60 mg, Denosumab, Produced by AryoGen Pharmed) Compared With Prolia® (60 mg, Denosumab, the Reference Drug, Produced by Amgen Company) in the Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women

TypeinterventionalSponsorAryoGen Pharmed Co.Ran2017 to 2020Enrolled190ConditionsOsteoporosisArmsDenosumab, calcium, vitamin D
3 · Its place in the literature

Who cites it

224 citing papers in PubMed, 18 syntheses or guidelines pooled it, 598 citations in OpenAlex.

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  6. Denosumab vs. bisphosphonates in primary osteoporosis: a meta-analysis of comparative safety in randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
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  10. Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
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  15. Denosumab compared to other treatments to prevent or treat osteoporosis in individuals at risk of fracture: a systematic review and 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 · 2016
    Pooled it
  16. 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
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  18. Evidence-based guidelines for the pharmacological treatment of postmenopausal osteoporosis: a consensus document by the Belgian Bone Club.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2010
    Guideline
  19. Phase 3 study comparing the efficacy and safety of proposed biosimilar RGB-14-P with denosumab in postmenopausal women with osteoporosis: results from the transition (switch) phase.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Trial
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164 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 8 countries.

Jacques P BrownLaval University, Le Centre Hospitalier Universitaire de Québec, Quebec City, Québec, Canada. jacques.brown@crchul.ulaval.ca
Richard L Prince
Chad Deal
Robert R Recker
Douglas P Kiel
Luiz H de Gregorio
Peyman Hadji
Lorenz C Hofbauer
Jose M Alvaro-Gracia
Huei Wang
Matthew Austin
Rachel B Wagman
Richard Newmark
Cesar Libanati
Javier San Martin
Henry G Bone
Amgen (United States) · USBristol-Myers Squibb (Germany) · DECleveland Clinic · USCreighton University · USHarvard University · USHospital Universitario de La Princesa · ESPhilipps University of Marburg · DESir Charles Gairdner Hospital · AUStanford University · USTU Dresden · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Denosumab is a fully human monoclonal antibody that inhibits bone resorption by neutralizing RANKL, a key mediator of osteoclast formation, function, and survival. This phase 3, multicenter, doubleblind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women with low bone mass. One thousand one hundred eighty-nine postmenopausal women with a T-score <or= -2.0 at the lumbar spine or total hip were randomized 1:1 to receive subcutaneous denosumab injections (60 mg every 6 mo [Q6M]) plus oral placebo weekly (n = 594) or oral alendronate weekly (70 mg) plus subcutaneous placebo injections Q6M (n = 595). Changes in BMD were assessed at the total hip, femoral neck, trochanter, lumbar spine, and one-third radius at 6 and 12 mo and in bone turnover markers at months 1, 3, 6, 9, and 12. Safety was evaluated by monitoring adverse events and laboratory values. At the total hip, denosumab significantly increased BMD compared with alendronate at month 12 (3.5% versus 2.6%; p < 0.0001). Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12-mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one-third radius; p <or= 0.0002 all sites). Denosumab treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab- and alendronate-treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments.

Indexed as

Bone DensityAdministration, OralAgedAlendronateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone and BonesBone Density Conservation AgentsBone RemodelingDenosumabFemaleHumansMiddle AgedPlacebosRANK LigandTime FactorsAlendronateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone Density Conservation AgentsDenosumabPlacebosRANK Ligand

Identifiers

PMID18767928
OpenAlexW2048964656

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.