PMID- 15026791
OWN - NLM
STAT- MEDLINE
DCOM- 20040422
LR  - 20220408
IS  - 0007-0920 (Print)
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Linking)
VI  - 90
IP  - 6
DP  - 2004 Mar 22
TI  - 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.
PG  - 1133-7
AB  - 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.
FAU - Body, J J
AU  - Body JJ
AD  - Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium. 
      jj.body@bordet.be
FAU - Diel, I J
AU  - Diel IJ
FAU - Lichinitzer, M
AU  - Lichinitzer M
FAU - Lazarev, A
AU  - Lazarev A
FAU - Pecherstorfer, M
AU  - Pecherstorfer M
FAU - Bell, R
AU  - Bell R
FAU - Tripathy, D
AU  - Tripathy D
FAU - Bergstrom, B
AU  - Bergstrom B
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Diphosphonates)
RN  - 0 (Placebos)
RN  - UMD7G2653W (Ibandronic Acid)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Neoplasms/*complications/*secondary
MH  - Bone Resorption
MH  - Breast Neoplasms/*pathology
MH  - Diphosphonates/*administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Fractures, Bone/etiology/prevention & control
MH  - Humans
MH  - Ibandronic Acid
MH  - Middle Aged
MH  - Morbidity
MH  - Placebos
MH  - Risk Factors
PMC - PMC2409647
EDAT- 2004/03/18 05:00
MHDA- 2004/04/23 05:00
PMCR- 2005/02/24
CRDT- 2004/03/18 05:00
PHST- 2004/03/18 05:00 [pubmed]
PHST- 2004/04/23 05:00 [medline]
PHST- 2004/03/18 05:00 [entrez]
PHST- 2005/02/24 00:00 [pmc-release]
AID - 6601663 [pii]
AID - 10.1038/sj.bjc.6601663 [doi]
PST - ppublish
SO  - Br J Cancer. 2004 Mar 22;90(6):1133-7. doi: 10.1038/sj.bjc.6601663.