Evidence map›Paper›PMID 31776637›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2020

Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates.

P D Miller, N Pannacciulli, J Malouf-Sierra, A Singer, E Czerwiński, H G Bone, C Wang, S Huang, A Chines, W Lems and 1 more

4 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 41 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 4 pooled it
3.0field-weighted citation impact, top 7% 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.

NCT00377819 phase3completednot on this map

A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density

TypeinterventionalSponsorAmgenRan2006 to 2008Enrolled504ConditionsPostmenopausal OsteoporosisArmsalendronate, Denosumab (AMG 162)
NCT00919711 phase3completednot on this map

A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned From Weekly or Daily Alendronate Therapy

TypeinterventionalSponsorAmgenRan2009 to 2012Enrolled870ConditionsOsteoporosisArmsActonel®, Denosumab
NCT00936897 phase3completednot on this map

A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

TypeinterventionalSponsorAmgenRan2009 to 2012Enrolled833ConditionsPostmenopausal OsteoporosisArmsIbandronate, Denosumab
NCT01732770 phase4completednot on this map

A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates

TypeinterventionalSponsorAmgenRan2012 to 2015Enrolled643ConditionsPost Menopausal OsteoporosisArmsDenosumab, Zoledronic Acid, Placebo to Denosumab, Placebo to Zoledronic Acid
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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
    Pooled it
  4. Association between bisphosphonate use and stroke risk: a 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 · 2023
    Pooled it
  5. 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
  6. 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
  7. Trial
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  9. Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
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  19. Medication-related osteonecrosis of the jaw: evolving research for multimodality medical management.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    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

11 authors at 7 institutions in 5 countries.

P D MillerColorado Center for Bone Research, 13991 Jubilee Trail, Pine, CO, 80470, USA. millerccbr@gmail.com.ORCID http://orcid.org/0000-0002-5347-7457
N PannacciulliAmgen Inc., Thousand Oaks, CA, USA.
J Malouf-SierraHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
A SingerGeorgetown University Medical Center, Washington, DC, USA.
E CzerwińskiKrakow Medical Center, Krakow, Poland.
H G BoneMichigan Bone and Mineral Clinic, Detroit, MI, USA.
C WangAmgen Inc., Thousand Oaks, CA, USA.
S HuangAmgen Inc., Thousand Oaks, CA, USA.
A ChinesAmgen Inc., Thousand Oaks, CA, USA.
W LemsVU University Medical Center, Amsterdam, The Netherlands.
J P BrownCHU de Québec Research Centre and Laval University, QC, Québec, Canada.
Amgen (United States) · USAmsterdam UMC Location Vrije Universiteit Amsterdam · NLColorado Center for Bone Research · USGeorgetown University · USHospital de Sant Pau · ESKrakow Cardiovascular Research Institute · PLUniversité Laval · CA

Funding

Amgen NA
6 · The paper itself

Abstract

Transitioning postmenopausal women with osteoporosis from a bisphosphonate to denosumab appears to be safe and more effective at improving BMD than continuing treatment with a bisphosphonate.

introductionWe conducted a patient-level pooled analysis of four studies to estimate the efficacy and safety of transitioning to denosumab vs. continuing bisphosphonate treatment in postmenopausal women who previously received oral bisphosphonates.

methodsPatients received 60 mg denosumab once every 6 months or a bisphosphonate (oral alendronate, risedronate, ibandronate, or intravenous zoledronic acid). Endpoints were change from baseline in lumbar spine, total hip, femoral neck, and 1/3 radius BMD at month 12, change from baseline in serum CTX-1 and P1NP, and incidence of adverse events.

resultsA total of 2850 randomized patients (1424 bisphosphonate:1426 denosumab) were included in the analysis. Percentage change in BMD was significantly greater (p < 0.001) for denosumab vs. bisphosphonate at each skeletal site; differences in BMD changes ranged from 0.6 to 2.0%. Percentage decrease in serum CTX-1 and P1NP was significantly greater (p < 0.0001) for denosumab vs. bisphosphonate at months 1, 6, and 12; in the denosumab group only, percentage change in serum CTX-1 at month 1 was significantly correlated with percentage change in lumbar spine and total hip BMD at month 12. The incidences of adverse events were similar between treatment groups. Three patients (one bisphosphonate and two denosumab) had atypical femoral fractures, all from the denosumab vs. zoledronic acid study.

conclusionPostmenopausal women can safely transition from a bisphosphonate to denosumab, which is more effective at improving BMD than continuing with a bisphosphonate. CLINICAL TRIALS REGISTRATION: NCT00377819, NCT00919711, NCT00936897, NCT01732770.

Indexed as

Bone Density Conservation AgentsDenosumabDiphosphonatesOsteoporosis, PostmenopausalAgedBone DensityFemaleHumansMiddle AgedPostmenopauseBone Density Conservation AgentsDenosumabDiphosphonatesBisphosphonateBone mineral densityDenosumabPooled analysisPostmenopausal women

Identifiers

PMID31776637
OpenAlexW2990127876

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.