Evidence map›Paper›PMID 15026791›Full record

Trial reportBritish journal of cancer2004

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.

J J Body, I J Diel, M Lichinitzer, A Lazarev, M Pecherstorfer, R Bell, D Tripathy, B Bergstrom

Open access · hybridAbstract readClinical TrialClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 6 pooled it
18.4field-weighted citation impact, top 1% 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

67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 334 citations in OpenAlex.

  1. Bisphosphonates and other bone agents for breast cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Adult cancer pain.Journal of the National Comprehensive Cancer Network : JNCCN · 2013
    Guideline
  6. NCCN Task Force Report: Bone Health in Cancer Care.Journal of the National Comprehensive Cancer Network : JNCCN · 2009
    Guideline
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Review
  15. Article
  16. Bone Metastasis in Bladder Cancer.Journal of personalized medicine · 2022
    Review
  17. Review
  18. Review
  19. Review
  20. Article

7 more citing papers are in PubMed but not listed here.

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

8 authors at 5 institutions in 5 countries.

J J BodyInstitut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. jj.body@bordet.be
I J Diel
M Lichinitzer
A Lazarev
M Pecherstorfer
R Bell
D Tripathy
B Bergstrom
Institut Jules Bordet · BERoche (Switzerland) · CHRussian Cancer Research Center NN Blokhin · RUThe University of Texas Southwestern Medical Center · USWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although intravenous (i.v.) bisphosphonates are the standard of care for metastatic bone disease, they are less than ideal for many patients due to infusion-related adverse events (AEs), an increased risk of renal toxicity and the inconvenience of regular hospital visits. The use of oral bisphosphonate therapy is limited by concerns over efficacy and gastrointestinal (GI) side effects. There remains a clinical need for an oral bisphosphonate that offers equivalent efficacy to i.v. bisphosphonates, good tolerability and dosing convenience. Oral ibandronate, a highly potent, third-generation aminobisphosphonate, has been evaluated in phase III clinical trials of patients with bone metastases from breast cancer. In two pooled phase III studies, patients with breast cancer and bone metastases were randomised to receive oral ibandronate 50 mg (n=287) or placebo (n=277) once daily for up to 96 weeks. The primary end point was the skeletal morbidity period rate (SMPR), defined as the number of 12-week periods with new skeletal complications. Multivariate Poisson's regression analysis was used to assess the relative risk of skeletal-related events in each treatment group during the study period. Oral ibandronate 50 mg significantly reduced the mean SMPR compared with placebo (0.95 vs 1.18, P=0.004). There was a significant reduction in the mean number of events requiring radiotherapy (0.73 vs 0.98, P<0.001) and events requiring surgery (0.47 vs 0.53, P=0.037). Poisson's regression analysis confirmed that oral ibandronate significantly reduced the risk of a skeletal event compared with placebo (hazard ratio 0.62, 95% CI=0.48, 0.79; P=0.0001). The incidence of mild treatment-related upper GI AEs was slightly higher in the oral ibandronate 50 mg group compared with placebo, but very few serious drug-related AEs were reported. Oral ibandronate 50 mg is an effective, well-tolerated and convenient treatment for the prevention of skeletal complications of metastatic bone disease.

Indexed as

Administration, OralAdultAgedAged, 80 and overBone NeoplasmsBone ResorptionBreast NeoplasmsDiphosphonatesFemaleFractures, BoneHumansIbandronic AcidMiddle AgedMorbidityPlacebosRisk FactorsDiphosphonatesIbandronic AcidPlacebos

Identifiers

PMID15026791
PMCPMC2409647
OpenAlexW2088500774

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.