Evidence map›Paper›PMID 30816640›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2019

Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial.

Kenneth G Saag, Nicola Pannacciulli, Piet Geusens, Jonathan D Adachi, Osvaldo D Messina, Jorge Morales-Torres, Ronald Emkey, Peter W Butler, Xiang Yin, Willem F Lems

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 11 pooled it
9.0field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 11 syntheses or guidelines pooled it, 137 citations in OpenAlex.

  1. Pooled it
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  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. 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
  12. Trial
  13. Trial
  14. 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
  15. Four-Year Teriparatide Followed by DenosumabFrontiers in endocrinology · 2021
    Trial
  16. Article
  17. Efficacy of romosozumab followed by denosumab in glucocorticoid users; a randomized clinical trial.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
  18. Review
  19. Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 4 countries.

Kenneth G SaagUniversity of Alabama at Birmingham.ORCID 0000-0001-6189-8078
Nicola PannacciulliAmgen Inc., Thousand Oaks, California.
Piet GeusensMaastricht University, Maastricht, The Netherlands.
Jonathan D AdachiMcMaster University, Hamilton, Ontario, Canada.
Osvaldo D MessinaCosme Argerich Hospital, Buenos Aires, Argentina.
Jorge Morales-TorresHospital Aranda de la Parra, León, Mexico.
Ronald EmkeyEmkey Arthritis & Osteoporosis Clinic, Wyomissing, Pennsylvania.
Peter W ButlerAmgen Inc., Thousand Oaks, California.
Xiang YinAmgen Inc., Thousand Oaks, California.
Willem F LemsVU University Medical Center, Amsterdam, The Netherlands.
Amgen (United States) · USAltoona Arthritis and Osteoporosis Center · USAmsterdam UMC Location Vrije Universiteit Amsterdam · NLArgerich Hospital · ARMaastricht University · NLMcMaster University · CAUniversity of Alabama at Birmingham · US

Funding

Amgen Inc.
6 · The paper itself

Abstract

objectiveClinical trial results have shown that, in glucocorticoid-treated patients, treatment with denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) at month 12 significantly more than treatment with risedronate 5 mg orally once daily (QD). The present analysis was performed to compare efficacy and characterize safety through month 24.

methodsThis phase III study enrolled men and women ≥18 years old who had received ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid-initiating) or for ≥3 months (glucocorticoid-continuing) before screening. All patients <50 years old had a history of osteoporotic fracture. Glucocorticoid-continuing patients ≥50 years old had T scores of -2.0 or less (or -1.0 or less with fracture history). Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D.

resultsOf 795 patients, 590 (74.2%) completed the study (in the glucocorticoid-initiating group, 109 of 145 patients treated with denosumab and 117 of 145 patients treated with risedronate; in the glucocorticoid-continuing group, 186 of 253 patients treated with denosumab and 178 of 252 patients treated with risedronate). Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid-initiating patients (24-month lumbar spine: BMD increase of 6.2% versus 1.7%, respectively [P < 0.001]; 24-month total hip: BMD increase of 3.1% versus 0.0% [P < 0.001]) and among glucocorticoid-continuing patients (24-month lumbar spine: BMD increase of 6.4% versus 3.2% [P < 0.001]; 24-month total hip: BMD increase of 2.9% versus 0.5% [P < 0.001]). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups.

conclusionDenosumab was superior to risedronate in terms of increases in spine and hip BMD through month 24, and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid-treated patients.

Indexed as

Bone DensityAbsorptiometry, PhotonAgedBone Density Conservation AgentsBone RemodelingCollagen Type IDenosumabDouble-Blind MethodFemaleFemur NeckGlucocorticoidsHipHumansLumbar VertebraeMaleMiddle AgedBone Density Conservation AgentsCollagen Type Icollagen type I trimeric cross-linked peptideDenosumabGlucocorticoidsPeptide FragmentsPeptidesProcollagenprocollagen Type I N-terminal peptideRisedronic Acid

Identifiers

PMID30816640
PMCPMC6619388
OpenAlexW2920578295

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.