Evidence map›Paper›PMID 20398352›Full record

Trial reportBreast cancer research : BCR2010

Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial.

Christos Markopoulos, Evagelos Tzoracoleftherakis, Athanassios Polychronis, Basileios Venizelos, Urania Dafni, Grigorios Xepapadakis, John Papadiamantis, Vasilios Zobolas, John Misitzis, Kyriakos Kalogerakos and 6 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 9 pooled it
5.3field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 9 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Effectiveness and safety of bone protective interventions to mitigate bone loss and skeletal fractures experienced by patients with non-metastatic breast cancer: a systematic review and 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 · 2026
    Pooled it
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  8. Guidance for the prevention of bone loss and fractures in postmenopausal women treated with aromatase inhibitors for breast cancer: an ESCEO position paper.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
    Guideline
  9. Pooled it
  10. Prevention of bone loss with risedronate in breast cancer survivors: a randomized, controlled clinical trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
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  16. Evaluation and management of skeletal disease in cancer care.Critical reviews in oncology/hematology · 2017
    Review
  17. Dietary Guidelines for Breast Cancer Patients: A Critical Review.Advances in nutrition (Bethesda, Md.) · 2017
    Review
  18. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Christos MarkopoulosHellenic Society of Breast Surgeons, 6 Eslin Street, Athens, Greece. cmarkop@hol.gr
Evagelos Tzoracoleftherakis
Athanassios Polychronis
Basileios Venizelos
Urania Dafni
Grigorios Xepapadakis
John Papadiamantis
Vasilios Zobolas
John Misitzis
Kyriakos Kalogerakos
Angeliki Sarantopoulou
Nikolaos Siasos
Dimitrios Koukouras
Zoh Antonopoulou
Spyros Lazarou
Helen Gogas
Senologic Hellenic Society · GRNational and Kapodistrian University of Athens · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A).

methodsPre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day).

resultsAt 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic.

conclusionsThe addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.

Indexed as

Administration, OralAgedAnastrozoleAromatase InhibitorsArthralgiaBone DensityBone Density Conservation AgentsBreast NeoplasmsDrug Therapy, CombinationDyspepsiaEtidronic AcidFemaleHumansMiddle AgedNauseaNitrilesAnastrozoleAromatase InhibitorsBone Density Conservation AgentsEtidronic AcidNitrilesRisedronic AcidTriazoles

Identifiers

PMID20398352
PMCPMC2879572
OpenAlexW1999427472

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.