A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma
| ISRCTN | ISRCTN38477744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38477744 |
| Protocol serial number | PR05 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funders | Medical Research Council (MRC) (UK), Boehringer Mannheim / Roche (Switzerland) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 12/04/2012
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=60
Contact information
Mr Matthew Sydes
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| Phone | +44 (0)207 6704700 |
|---|---|
| matthew.sydes@ctu.mrc.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind placebo-controlled randomised trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Measure the efficacy and safety of oral sodium clodronate in preventing symptomatic bone disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | 1. One group receives 3 years of oral sodium clodronate 2. The other group receives a matching placebo for 3 years |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral sodium clodronate |
| Primary outcome measure(s) |
Time to symptomatic bone progression; overall survival; impact on analgesic consumption. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 311 |
| Key inclusion criteria | 1. Proven histological diagnosis of prostate cancer or Prostate-Specific Antigen (PSA) more than 100 mg/l 2. Metastatic bone disease demonstrated on bone scan or skeletal radiographs (Stage M1b) 3. Patients commencing or clinically responding to initial hormone treatment with orchidectomy, Luteinising Hormone Releasing Hormone (LHRH) analogues, cyproterone acetate, flutamide or complete androgen blockade but with no previous hormone treatment 4. Normocalcaemic (serum calcium within the normal range of the centre) 5. WHO performance status of 0, 1 or 2 6. No concomitant or previous use of other bisphosphonates 7. Serum creatinine less than twice upper limit of normal range of centre 8. No administration of any investigational drug within 12 months |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/1994 |
| Date of final enrolment | 01/07/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
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 | 03/09/2003 | Yes | No | |
| Results article | results | 01/09/2009 | Yes | No |
