Evidence map›Paper›PMID 19671656›Full record

Trial reportThe New England journal of medicine2009

Denosumab in men receiving androgen-deprivation therapy for prostate cancer.

Matthew R Smith, Blair Egerdie, Narciso Hernández Toriz, Robert Feldman, Teuvo L J Tammela, Fred Saad, Jiri Heracek, Maciej Szwedowski, Chunlei Ke, Amy Kupic and 3 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00089674 (A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer), which is not on this map. Cited by 408 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
408citing papers in PubMed, 18 pooled it
56.7field-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.

NCT00089674 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

TypeinterventionalSponsorAmgenRan2004 to 2010Enrolled1,468ConditionsProstate CancerArmsAMG 162, Placebo
3 · Its place in the literature

Who cites it

408 citing papers in PubMed, 18 syntheses or guidelines pooled it, 1,121 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. 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
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Guideline
  15. Hypocalcemia and bone mineral density changes following denosumab treatment in end-stage renal disease patients: a meta-analysis of observational studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018
    Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Trial
  20. A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with 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 · 2025
    Trial

348 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 at 9 institutions in 6 countries.

Matthew R SmithMassachusetts General Hospital Cancer Center, Boston, MA 02114, USA. smith.matthew@mgh.harvard.edu
Blair Egerdie
Narciso Hernández Toriz
Robert Feldman
Teuvo L J Tammela
Fred Saad
Jiri Heracek
Maciej Szwedowski
Chunlei Ke
Amy Kupic
Benjamin Z Leder
Carsten Goessl
Denosumab HALT Prostate Cancer Study Group
Amgen (United States) · USCentre Hospitalier de l’Université de Montréal · CACentro Medico Nacional Siglo XXI · MXDermatology Specialists · USEndocrine Society · USEnergy and Environmental Consultancy · CZHarvard University · USTampere University · FIWojewódzki Ośrodek Medycyny Pracy · PL

Funding

Midcareer Investigator AwardK24CA121990 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, MATTHEW RAYMOND · 2007 to 2016
$1.9M
NCI NIH HHS 5K24CA121990-02NCI NIH HHS K24 CA121990
6 · The paper itself

Abstract

backgroundAndrogen-deprivation therapy is well-established for treating prostate cancer but is associated with bone loss and an increased risk of fracture. We investigated the effects of denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, on bone mineral density and fractures in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer.

methodsIn this double-blind, multicenter study, we randomly assigned patients to receive denosumab at a dose of 60 mg subcutaneously every 6 months or placebo (734 patients in each group). The primary end point was percent change in bone mineral density at the lumbar spine at 24 months. Key secondary end points included percent change in bone mineral densities at the femoral neck and total hip at 24 months and at all three sites at 36 months, as well as incidence of new vertebral fractures.

resultsAt 24 months, bone mineral density of the lumbar spine had increased by 5.6% in the denosumab group as compared with a loss of 1.0% in the placebo group (P<0.001); significant differences between the two groups were seen at as early as 1 month and sustained through 36 months. Denosumab therapy was also associated with significant increases in bone mineral density at the total hip, femoral neck, and distal third of the radius at all time points. Patients who received denosumab had a decreased incidence of new vertebral fractures at 36 months (1.5%, vs. 3.9% with placebo) (relative risk, 0.38; 95% confidence interval, 0.19 to 0.78; P=0.006). Rates of adverse events were similar between the two groups.

conclusionsDenosumab was associated with increased bone mineral density at all sites and a reduction in the incidence of new vertebral fractures among men receiving androgen-deprivation therapy for nonmetastatic prostate cancer. (ClinicalTrials.gov number, NCT00089674.)

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone DensityBone Density Conservation AgentsBone RemodelingDenosumabDouble-Blind MethodFractures, BoneGonadotropin-Releasing HormoneHumansIncidenceInjections, SubcutaneousLumbar VertebraeAndrogen AntagonistsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone Density Conservation AgentsDenosumabGonadotropin-Releasing HormoneRANK Ligand

Identifiers

PMID19671656
PMCPMC3038121
OpenAlexW1992053982

What OpenQuestion holds

Textmetadata
LicenceTDM
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.