A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma

ISRCTN	ISRCTN38477744
DOI	https://doi.org/10.1186/ISRCTN38477744
Secondary identifying numbers	PR05

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Mr Matthew Sydes
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Phone	+44 (0)207 6704700
Email	matthew.sydes@ctu.mrc.ac.uk

Study design	Double blind placebo-controlled randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oral sodium clodronate
Primary outcome measure	Time to symptomatic bone progression; overall survival; impact on analgesic consumption.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/1994
Completion date	01/07/1998

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Boehringer Mannheim / Roche (Switzerland)

No information available

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

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