Evidence map›Paper›PMID 31999376›Full record

ArticleJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2020

A Pooled Analysis of Fall Incidence From Placebo-Controlled Trials of Denosumab.

Pojchong Chotiyarnwong, Eugene McCloskey, Richard Eastell, Michael R McClung, Evelien Gielen, John Gostage, Michele McDermott, Arkadi Chines, Shuang Huang, Steven R Cummings

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01732770 (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), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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.

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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Anti-resorptive and anabolic therapies improve Falls Risk Assessment Score (FRAS) in postmenopausal women with type 2 diabetes mellitus.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
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Among people on osteoporosis medication, loss of appendicular or total body lean mass is an independent risk factor for hip and major osteoporotic fractures.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Sclerostin: clinical insights in muscle-bone crosstalk.The Journal of international medical research · 2023
    Review
  16. Beneficial effects of denosumab on muscle performance in patients with low BMD: a retrospective, propensity score-matched study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Article
  17. Article
  18. Skeletal Aging.Mayo Clinic proceedings · 2022
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Pojchong ChotiyarnwongDepartment of Orthopaedic Surgery, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Eugene McCloskeyAcademic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.ORCID 0000-0003-0177-8140
Richard EastellAcademic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.
Michael R McClungOregon Osteoporosis Center, Portland, OR, USA.
Evelien GielenCenter for Metabolic Bone Diseases, University Hospitals Leuven, and Department of Chronic Diseases, Metabolism, and Aging, (CHROMETA), KU Leuven, Leuven, Belgium.
John GostageAcademic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.
Michele McDermottAmgen Inc., Thousand Oaks, CA, USA.
Arkadi ChinesAmgen Inc., Thousand Oaks, CA, USA.
Shuang HuangAmgen Inc., Thousand Oaks, CA, USA.
Steven R CummingsSan Francisco Coordinating Center, California Pacific Medical Center (CPMC), Research Institute and the University of California, San Francisco, CA, USA.ORCID 0000-0001-8808-260X
Amgen (United States) · USUniversity of Sheffield · GBBone Health and Osteoporosis Foundation · USKU Leuven · BESiriraj Hospital · THUniversity of California, San Francisco · US

Funding

Medical Research Council MR/P020941/1
6 · The paper itself

Abstract

Recent studies suggest that the RANK/RANKL system impacts muscle function and/or mass. In the pivotal placebo-controlled fracture trial of the RANKL inhibitor denosumab in women with postmenopausal osteoporosis, treatment was associated with a lower incidence of non-fracture-related falls (p = 0.02). This ad hoc exploratory analysis pooled data from five placebo-controlled trials of denosumab to determine consistency across trials, if any, of the reduction of fall incidence. The analysis included trials in women with postmenopausal osteoporosis and low bone mass, men with osteoporosis, women receiving adjuvant aromatase inhibitors for breast cancer, and men receiving androgen deprivation therapy for prostate cancer. The analysis was stratified by trial, and only included data from the placebo-controlled period of each trial. A time-to-event analysis of first fall and exposure-adjusted subject incidence rates of falls were analyzed. Falls were reported and captured as adverse events. The analysis comprised 10,036 individuals; 5030 received denosumab 60 mg subcutaneously once every 6 months for 12 to 36 months and 5006 received placebo. Kaplan-Meier estimates showed an occurrence of falls in 6.5% of subjects in the placebo group compared with 5.2% of subjects in the denosumab group (hazard ratio = 0.79; 95% confidence interval 0.66-0.93; p = 0.0061). Heterogeneity in study designs did not permit overall assessment of association with fracture outcomes. In conclusion, denosumab may reduce the risk of falls in addition to its established fracture risk reduction by reducing bone resorption and increasing bone mass. These observations require further exploration and confirmation in studies with muscle function or falls as the primary outcome. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research..

Indexed as

Bone Density Conservation AgentsOsteoporosis, PostmenopausalProstatic NeoplasmsAccidental FallsAndrogen AntagonistsBone DensityDenosumabHumansIncidenceMaleRandomized Controlled Trials as TopicAndrogen AntagonistsBone Density Conservation AgentsDenosumabAGINGANTIRESORPTIVESFRACTURE PREVENTIONOSTEOPOROSIS

Identifiers

PMID31999376
PMCPMC9328365
OpenAlexW3003826544

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.