Evidence map›Paper›PMID 36190391›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2022

The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial.

Edward Czerwinski, Jose Cardona, Rafal Plebanski, Chris Recknor, Tamara Vokes, Kenneth G Saag, Neil Binkley, E Michael Lewiecki, Jonathan Adachi, Dorota Knychas and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03512262 (A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis), which is not on this map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
1.1field-weighted citation impact, top 25% 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.

NCT03512262 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

TypeinterventionalSponsorRadius Health, Inc.Ran2018 to 2021Enrolled228ConditionsOsteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related OsteoporosisArmsAbaloparatide, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Probability of achieving bone mineral density treatment targets with abaloparatide and teriparatide.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025
    Trial
  7. Trial
  8. Review
  9. Three months of abaloparatide treatment rapidly improves bone formation and density: implications for orthopedic preoperative bone health optimization.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
  10. Anabolics in Cancer Patients: To Use or Not to Use?Endocrinology and metabolism (Seoul, Korea) · 2026
    Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Bone health in cancer: perspective on the use of osteoanabolic agents.Therapeutic advances in endocrinology and metabolism · 2025
    Review
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

16 authors at 10 institutions in 3 countries.

Edward CzerwinskiKrakow Medical Center, Krakow, Poland.
Jose CardonaIndago Research & Health Center, Hialeah, FL, USA.
Rafal PlebanskiClinic of Healthy Bones, Londz, Poland.
Chris RecknorCenter for Advanced Research & Education, Gainesville, GA, USA.
Tamara VokesThe University of Chicago, Chicago, IL, USA.
Kenneth G SaagThe University of Alabama at Birmingham, Birmingham, AL, USA.ORCID 0000-0001-6189-8078
Neil BinkleyUniversity of Wisconsin Osteoporosis Clinical Research Program, Madison, WI, USA.ORCID 0000-0002-9905-461X
E Michael LewieckiNew Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.ORCID 0000-0003-2026-9587
Jonathan AdachiMcMaster University, Hamilton, Ontario, Canada.
Dorota KnychasSynexus Warsaw Medical Center, Warsaw, Poland.
David KendlerUniversity of British Columbia, Vancouver, British Columbia, Canada.
Eric OrwollOregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-8520-7355
Yinzhong ChenRadius Health, Inc., Boston, MA, USA.
Leny PearmanRadius Health, Inc., Boston, MA, USA.
Y Heather LiRadius Health, Inc., Boston, MA, USA.
Bruce MitlakRadius Health, Inc., Boston, MA, USA.ORCID 0000-0001-7050-0703
Radius Health (United States) · USKrakow Cardiovascular Research Institute · PLMcMaster University · CAMedical University of Warsaw · PLNew Mexico Clinical Research & Osteoporosis Center · USOregon Health & Science University · USUniversity of Alabama at Birmingham · USUniversity of British Columbia · CAUniversity of Chicago · USUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Abaloparatide significantly increased bone mineral density (BMD) in women with postmenopausal osteoporosis and decreased risk of vertebral, nonvertebral, and clinical fractures compared with placebo. The Abaloparatide for the Treatment of Men with Osteoporosis (ATOM; NCT03512262) study evaluated the efficacy and safety of abaloparatide compared with placebo in men. Eligible men aged 40 to 85 years with osteoporosis were randomized 2:1 to daily subcutaneous injections of abaloparatide 80 μg or placebo for 12 months. The primary endpoint was change from baseline in lumbar spine BMD. Key secondary endpoints included BMD change from baseline at the total hip and femoral neck. A total of 228 men were randomized (abaloparatide, n = 149; placebo, n = 79). Baseline characteristics were similar across treatment groups (mean age, 68.3 years; mean lumbar spine BMD T-score, -2.1). At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (least squares mean percentage change [standard error]: 8.48 [0.54] versus 1.17 [0.72]), total hip (2.14 [0.27] versus 0.01 [0.35]), and femoral neck (2.98 [0.34] versus 0.15 [0.45]) (all p < 0.0001). The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache. During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies. These results suggest abaloparatide can be considered as an effective anabolic treatment option for men with osteoporosis. © 2022 Radius Health Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Indexed as

Bone Density Conservation AgentsOsteoporosisParathyroid Hormone-Related ProteinAgedBone DensityDouble-Blind MethodFemur NeckHumansMaleabaloparatideBone Density Conservation AgentsParathyroid Hormone-Related ProteinABALOPARATIDEBONE MINERAL DENSITYFRACTUREMENOSTEOPOROSIS

Identifiers

PMID36190391
PMCPMC10091818
OpenAlexW4300690014

What OpenQuestion holds

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LicenceCC BY
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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.