Plain English Summary
Trial website
Additional identifiers
EudraCT number
2005-001710-40
ClinicalTrials.gov number
NCT00326820
Protocol/serial number
N/A
Study information
Scientific title
A randomised pragmatic open-label, multicentre, non-crossover clinical study to evaluate and compare the efficacy, safety profile and tolerability of oral ibandronate versus intravenous (iv) zoledronate in the treatment of breast cancer patients with bone metastases
Acronym
ZICE (Zoledronate vs Ibandronate Comparative Evaluation)
Study hypothesis
To demonstrate non-inferiority of oral ibandronate 50 mg daily in comparison with 34 weekly zoledronate 4 mg iv infusions and investigate the tolerability and side-effect profile of the two study arms.
Ethics approval
MREC for Wales on 19/08/2005. (MREC ref: 05/MRE09/57)
Study design
randomised pragmatic open-label, multicentre, non-crossover clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Breast cancer with bone metastases
Intervention
Comparison of skeletal related events in patients on iv zoledronate given 3-4 weekly and oral daily ibandronate.
Blood samples analysed 3-4 weekly; lumbar and thoracic plain spine X-rays at baseline and end of treatment. Analysis of quality of life (QoL), analgesic usage and pain scoring.
Intervention type
Drug
Phase
Phase III
Drug names
Zoledronate, Ibandronate
Primary outcome measure
Mean number of skeletal related events (SREs) per patient
Secondary outcome measures
Time to first SRE; Andersen-Gill Multiple-event analysis; Percentage of patients with any SRE; Pain/analgesic scores; Safety (including survival); Quality of Life (QoL); Cost efficiency analysis.
Overall trial start date
01/09/2005
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with newly diagnosed (<3 months) multiple bone metastases from histologically proven breast cancer and considered suitable for treatment with a bisphosphonate
2. Isotope bone scan within 6 weeks prior to screening to provide evidence of multiple bone metastases
3. Patients may also be receiving chemotherapy and/or hormone therapy for metastatic disease
4. Patients with multiple (>1) bone metastases (painful or asymptomatic) of lytic, mixed or purely sclerotic type
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1400
Participant exclusion criteria
1. Patients with a creatinine clearance of less than 30 ml/minute
2. Patients with serum bilirubin/aspartate transaminase (AST) (alanine transaminase [ALT]) raised more than 1.5 times normal
3. Patients with central nervous system (CNS) metastases
4. Patients who have undergone dental procedures in the 2 months prior to randomisation
5. Patients with known active peptic ulcer
6. Patients with hypocalcaemia within 6 weeks of randomisation
7. Patients who have received bisphosphonate therapy in the previous 6 months
Recruitment start date
01/09/2005
Recruitment end date
30/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Velindre NHS Trust
Cardiff
CF14 2TL
United Kingdom
Funders
Funder type
Industry
Funder name
Roche Pharmaceuticals UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24107437
Publication citations
-
Nelson A, Fenlon D, Morris J, Sampson C, Harrop E, Murray N, Wheatley D, Hood K, Griffiths G, Barrett-Lee P, QUALZICE: a QUALitative exploration of the experiences of the participants from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates., Trials, 2013, 14, 325, doi: 10.1186/1745-6215-14-325.