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
| ISRCTN | ISRCTN13914201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13914201 |
| EudraCT/CTIS number | 2005-001710-40 |
| ClinicalTrials.gov number | NCT00326820 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/03/2005
- Registration date
- 13/04/2005
- Last edited
- 26/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Peter Barrett-Lee
Scientific
Scientific
Velindre NHS Trust
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Study information
| Study design | randomised pragmatic open-label, multicentre, non-crossover clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study acronym | ZICE (Zoledronate vs Ibandronate Comparative Evaluation) |
| Study objectives | 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(s) | MREC for Wales on 19/08/2005. (MREC ref: 05/MRE09/57) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2005 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Velindre NHS Trust
Cardiff
CF14 2TL
United Kingdom
CF14 2TL
United Kingdom
Sponsor information
Velindre NHS Trust
Industry
Industry
Unit 2, Charnwood Court
Parc Nantgarw
Nantgarw
Cardiff
CF15 7QW
United Kingdom
"ROR" |
https://ror.org/05ntqkc30 |
|---|
Funders
Funder type
Industry
Roche Pharmaceuticals UK
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | sub-study results | 09/10/2013 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
