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 |
| ClinicalTrials.gov (NCT) | NCT00326820 |
| Clinical Trials Information System (CTIS) | 2005-001710-40 |
| Protocol serial number | N/A |
| Sponsor | Velindre NHS Trust |
| Funder | Roche Pharmaceuticals UK |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | randomised pragmatic open-label, multicentre, non-crossover clinical study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Zoledronate, Ibandronate |
| Primary outcome measure(s) |
Mean number of skeletal related events (SREs) per patient |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | sub-study results | 09/10/2013 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
