A randomised controlled clinical trial to evaluate the anti-osteolytic agent clodronate for the prevention of the development of bone metastases in patients with primary breast cancer
| ISRCTN | ISRCTN83688026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83688026 |
| Protocol serial number | N/A |
| Sponsor | Royal Marsden Hospital (UK), secondary sponsor Schering (Germany) |
| Funders | Royal Marsden hospital research fund (UK), Leiras Oy (Finland) |
- Submission date
- 01/02/2006
- Registration date
- 01/02/2006
- Last edited
- 22/08/2012
- 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
Not provided at time of registration
Contact information
Prof Trevor Powles
Scientific
Scientific
Parkside Oncology Clinic
49 Parkside
Wimbledon
London
SW19 4NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled, multicentre, phase III trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | That the use of the anti-osteolytic bisphosphonate clodronate will prevent the development of bone metastases in patients with primary operable breast cancer |
| Ethics approval(s) | Royal Marsden Hospital Research Ethics Committee, protocol number 444, approval received 1988 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Clodronate 1600 mg taken orally per day for two years |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bisphosphonate clodronate |
| Primary outcome measure(s) |
Time to first bone metastases over five-year study period |
| Key secondary outcome measure(s) |
Survival |
| Completion date | 01/01/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1000 |
| Key inclusion criteria | Histologically or cytologically confirmed primary operable breast cancer with no evidence of metastases |
| Key exclusion criteria | 1. Significant renal, hepatic or non-malignant bone disease 2. Previous history of malignant disease 3. Prior bisphosphonate use |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 01/01/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Parkside Oncology Clinic
London
SW19 4NB
United Kingdom
SW19 4NB
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 | results | 01/03/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
