Condition category
Cancer
Date applied
10/03/2005
Date assigned
13/04/2005
Last edited
29/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter Barrett-Lee

ORCID ID

Contact details

Velindre NHS Trust
Whitchurch
Cardiff
CF14 2TL
United Kingdom

Additional identifiers

EudraCT number

2005-001710-40

ClinicalTrials.gov number

NCT00326820

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ZICE (Zoledronate vs Ibandronate Comparative Evaluation)

Study hypothesis

To demonstrate non-inferiority of oral ibandronate 50 mg daily in comparison with 3–4 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 measures

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

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

Sponsor information

Organisation

Velindre NHS Trust

Sponsor details

Unit 2
Charnwood Court
Parc Nantgarw
Nantgarw
Cardiff
CF15 7QW
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2013 sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24107437

Publication citations

  1. 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.

Additional files

Editorial Notes