Evidence map›Paper›PMID 23749244›Full record

Trial reportClinical oral investigations2014

Prevalence of bisphosphonate-associated osteonecrosis of the jaw after intravenous zoledronate infusions in patients with early breast cancer.

Petra Rugani, Gero Luschin, Norbert Jakse, Barbara Kirnbauer, Uwe Lang, Stephan Acham

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical oral investigations, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00295646 (Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT00295646 phase3completednot on this map

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

TypeinterventionalSponsorAustrian Breast & Colorectal Cancer Study GroupRan1999 to 2018Enrolled1,803ConditionsBreast CancerArmstamoxifen, anastrozole, zoledronic acid, goserelin
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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  6. Drug-related jaw osteonecrosis: a 6-year retrospective study from two centers in Argentina.Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina) · 2025
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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

6 authors at 2 institutions in 2 countries.

Petra RuganiDepartment of Oral Surgery and Radiology, Medical University of Graz, Auenbruggerplatz 12, 8036, Graz, Austria, petra.rugani@medunigraz.at.
Gero Luschin
Norbert Jakse
Barbara Kirnbauer
Uwe Lang
Stephan Acham
Medical University of Graz · ATWomen's Health Research Institute · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe definite incidence rate of bisphosphonate-related osteonecrosis of the jaws (BRONJ) is still unknown. The aim of this study was to investigate prevalence of BRONJ in a group of breast cancer patients applying the classification of the Association of Oral and Maxillofacial Surgeons 2009. PATIENTS AND

methodsBetween 2000 and 2008, 63 premenopausal early breast cancer patients who were free of metastases were treated with 4 mg zoledronic acid every 6 months over 3 years as participants of a multicenter, randomized, controlled, adjuvant breast cancer medication trial. Patients were not informed about the risk of jaw necrosis. None reported tooth or jaw complaints during the breast cancer follow-up examinations. In 2010, 48 patients of this cohort were investigated concerning BRONJ by clinical and radiological examinations.

resultsNo advanced stages (AAOMS 2009)were detected. However, five patients (10.4%) presented purulent (2) and nonpurulent (3) fistulas and radiological signs correlating to BRONJ stage 0.

conclusionAlthough no case of advanced BRONJ was detected, the study revealed a high prevalence of BRONJ stage 0. This supports the need for tight cooperation between dentists and medical specialists prescribing bisphosphonates including dental pre-therapeutic and follow-up examinations. Adaption of the BRONJ classification taking account to bone exposure via fistulas is recommended. CLINICAL RELEVANCE: BRONJ is said to be a complication linked to high-dosage bisphosphonate therapy. The study demonstrates that even after application of zoledronate in a low-dose protocol, early BRONJ occurred. Radiological signs solely are not sufficient to confirm BRONJ; clinical signs are mandatory.

Indexed as

AdultAgedBisphosphonate-Associated Osteonecrosis of the JawBreast NeoplasmsDiphosphonatesFemaleHumansImidazolesMiddle AgedPrevalenceZoledronic AcidDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID23749244
OpenAlexW2056411056

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.