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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised, double-blind, placebo-controlled, multicentre, phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bisphosphonate clodronate |
| Primary outcome measure | Time to first bone metastases over five-year study period |
| Secondary outcome measures | Survival |
| Overall study start date | 01/01/1989 |
| Completion date | 01/01/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Parkside Oncology Clinic
London
SW19 4NB
United Kingdom
SW19 4NB
United Kingdom
Sponsor information
Royal Marsden Hospital (UK), secondary sponsor Schering (Germany)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
| Website | http://www.royalmarsden.org |
|---|---|
"ROR" |
https://ror.org/034vb5t35 |
Funders
Funder type
Other
Royal Marsden hospital research fund (UK)
No information available
Leiras Oy (Finland)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2006 | Yes | No |
