Evidence map›Paper›PMID 21324674›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2011

Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809.

C L Shapiro, S Halabi, V Hars, L Archer, D Weckstein, J Kirshner, W Sikov, E Winer, H J Burstein, C Hudis and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 5 pooled it
4.6field-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

42 citing papers in PubMed, 5 syntheses or guidelines pooled it, 102 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
  2. Pooled it
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  5. Pooled it
  6. Trial
  7. Effects of zoledronic acid versus placebo on bone mineral density and bone texture analysis assessed by the trabecular bone score in premenopausal women with breast cancer treatment-induced bone loss: results of the ProBONE II substudy.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Trial
  8. Effects of zoledronic acid on bone mineral density in premenopausal women receiving neoadjuvant or adjuvant therapies for HR+ breast cancer: the ProBONE II study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2014
    Trial
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  16. Management of bone loss due to endocrine therapy during cancer treatment.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Review
  17. Review
  18. Review
  19. Effect of cytotoxic chemotherapy on bone health among breast cancer patients. Does it require intervention?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Review
  20. Article
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

13 authors at 10 institutions in 1 country.

C L ShapiroOhio State University Medical Center and James Cancer Hospital, Columbus, OH 43210, USA. charles.shapiro@osumc.edu
S Halabi
V Hars
L Archer
D Weckstein
J Kirshner
W Sikov
E Winer
H J Burstein
C Hudis
C Isaacs
R Schilsky
E Paskett
Dana-Farber Cancer Institute · USGeorgetown University Medical Center · USHarvard University · USHematology Oncology Associates of Central New York · USMemorial Sloan Kettering Cancer Center · USNew Hampshire Hospital · USRhode Island Hospital · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe Ohio State University Wexner Medical Center · USUniversity of Chicago · US

Funding

PREMATURE OVARIAN FAILURE IN BREAST CANCER PATIENTSR29CA060050 · NCI · OHIO STATE UNIVERSITY · PI SHAPIRO, CHARLES L · 1994 to 1998
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NCI NIH HHS R29 CA060050
6 · The paper itself

Abstract

backgroundChemotherapy-induced ovarian failure (CIOF) is a frequent side-effect of adjuvant chemotherapy that results in rapid bone loss. We hypothesised that zoledronic acid (ZA), a third-generation amino bisphosphonate, would prevent bone loss in premenopausal women who developed CIOF.

methodsWomen (439) were randomised to intravenous (i.v.) ZA 4 mg every 3 months for 2 years starting within 1-3 months after randomization (arm A) or 1 year after randomization (arm B, controls). CIOF was prospectively defined as ≥ 3 months of amenorrhoea, follicle-stimulating hormone (FSH) ≥ 30 MIU/ml and non-pregnant at 1 year. The primary end-point was the percentage change in bone mineral density (BMD) in the lumbar spine (LS) from baseline to 12 months in the ZA and in control groups in women who developed CIOF; the secondary end-point was BMD in LS at 3 years in all randomised women.

findingsOne hundred and fifty (56%) met the definition of CIOF at 1 year. Overall, grade 3 toxicities of ZA were fatigue (1%) arthralgias (21%) and pain (84%). The median percent change (interquartile range, IQR) at 1 year was +1.2% (-0.5% to +2.8%) and -6.7% (-9.7% to -2.9%) p<0.001 and at 3 years was +1.0% (-1.6% to +5.2%) and -0.5% (-3.7% to +3.2%) p=0.019 in arms A and B, respectively.

interpretationZA every 3 months is well tolerated and prevents rapid bone loss in premenopausal women that develop CIOF. Giving ZA with rather than 1 year after the start of adjuvant chemotherapy is the preferred sequence to prevent bone loss.

Indexed as

PremenopauseAdultAntineoplastic AgentsBone DensityBone Density Conservation AgentsBreast NeoplasmsChemotherapy, AdjuvantDiphosphonatesFatigueFemaleFeverHumansImidazolesInfusions, IntravenousMiddle AgedPainAntineoplastic AgentsBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID21324674
PMCPMC4211594
OpenAlexW2109375600

What OpenQuestion holds

Textmetadata
LicenceTDM
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.