Evidence map›Paper›PMID 32929540›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2021

Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307).

Darya A Kizub, Jieling Miao, Mark M Schubert, Alexander H G Paterson, Mark Clemons, Elizabeth C Dees, James N Ingle, Carla I Falkson, William E Barlow, Gabriel N Hortobagyi and 1 more

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

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00127205 (Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 15% 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.

NCT00127205 phase3completednot on this map

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2005 to 2021Enrolled6,097ConditionsBreast CancerArmsclodronate disodium, ibandronate sodium, zoledronic acid
3 · Its place in the literature

Who cites it

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

  1. MASCC/ISOO Clinical Practice Statement: Adjuvant bone-modifying agents in primary breast cancer patients - prevention of medication-related osteonecrosis of the jaw.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Guideline
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Observational
  7. Article
  8. Article
  9. [Bisphosphonates-related osteonecrosis of the jaw: A case report].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2025
    Article
  10. Article
  11. Article
  12. Bridging the gap - Establishing a dental-oncology service in a cancer centre.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  13. How we manage medication-related osteonecrosis of the jaw.European journal of medical research · 2024
    Review
  14. 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
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. 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

11 authors at 8 institutions in 2 countries.

Darya A KizubThe Everett Clinic, Everett, WA, USA. daryakizub@gmail.com.ORCID http://orcid.org/0000-0001-7925-2785
Jieling MiaoSWOG Statistical Center, Seattle, WA, USA.
Mark M SchubertFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Alexander H G PatersonTom Baker Cancer Center, Calgary, Alberta, Canada.
Mark ClemonsOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Elizabeth C DeesUniversity of North Carolina, Chapel Hill, NC, USA.
James N IngleMayo Clinic, Rochester, MN, USA.
Carla I FalksonWilmot Cancer Center at the University of Rochester, Rochester, NY, USA.
William E BarlowSWOG Statistical Center, Seattle, WA, USA.
Gabriel N HortobagyiUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Julie R GralowUniversity of Washington School of Medicine, Seattle, WA, USA.
Cancer Research And Biostatistics · USUniversity of Washington · USEverett Community College · USMayo Clinic in Arizona · USOttawa Hospital · CAThe University of Texas MD Anderson Cancer Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Rochester · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MEGAN OTHUS · 2014 to 2026
$115.2M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Targeted immunotherapy of breast cancer with central memory T cellsP50CA138293 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI PORTER, PEGGY L. · 2010 to 2014
$11.0M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCI NIH HHS NCI CA180888, CA180819, CA180820, CA180821, CA180868, CA180863NCI NIH HHS P50 CA138293NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

purposeBisphosphonates reduce bone metastases in postmenopausal women with early-stage breast cancer but carry the risk of bisphosphonate-related osteonecrosis of the jaw (BRONJ). We describe risk factors for BRONJ and compare BRONJ provoked by infection or trauma with spontaneous lesions, which carry a better prognosis.

methodsSWOG 0307 randomized women with stage I-III breast cancer to receive zoledronic acid (ZA), clodronate (CL), or ibandronate (IB) for 3 years, implemented BRONJ prevention guidelines, and collected information about dental health and development of BRONJ. All statistical tests were two-sided.

resultsOf 6018 women, 48 developed BRONJ. Infection was present in 21 (43.8%). Median time to BRONJ was 2.1 years for ZA, 2.0 years for IB, and 3.4 years for clodronate (p = 0.04). BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05). Of 57 lesions, BRONJ occurred spontaneously in 20 (35.1%) and was provoked by dental extraction in 20 (35.1%), periodontal disease in 14 (24.6%), denture trauma in 6 (10.5%), and dental surgery in 2 (3.5%). Spontaneous BRONJ occurred more frequently at the mylohyoid ridge. There were no differences in dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ.

conclusionZA and worse dental health were associated with increased incidence of BRONJ, with a trend toward additive risk when combined. BRONJ incidence was lower than in similar studies, with prevention strategies likely linked to this. CLINICAL TRIAL NUMBER: NCT00127205 REGISTRATION DATE: July 2005.

Indexed as

Bisphosphonate-Associated Osteonecrosis of the JawBone Density Conservation AgentsBreast NeoplasmsChemotherapy, AdjuvantDiphosphonatesFemaleHumansPrognosisProspective StudiesRisk FactorsBone Density Conservation AgentsDiphosphonatesBisphosphonateBreast cancerClinical trialsOsteonecrosis of the jaw

Identifiers

PMID32929540
PMCPMC7956914
OpenAlexW3086006009

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.