Welcome
Support Centre
23 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma
ISRCTN ISRCTN38477744
DOI 10.1186/ISRCTN38477744
ClinicalTrials.gov identifier
EudraCT number
Public title A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma
Scientific title
Acronym N/A
Serial number at source PR05
Study hypothesis Measure the efficacy and safety of oral sodium clodronate in preventing symptomatic bone disease
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=60
Ethics approval Not provided at time of registration
Study design Double blind placebo-controlled randomised trial
Countries of recruitment United Kingdom
Disease/condition/study domain Prostate cancer
Participants - 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
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/06/1994
Anticipated end date 01/07/1998
Status of trial Completed
Patient information material
Target number of participants 311
Interventions 1. One group receives 3 years of oral sodium clodronate
2. The other group receives a matching placebo for 3 years
Primary outcome measure(s) Time to symptomatic bone progression; overall survival; impact on analgesic consumption.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Medical Research Council (MRC) (UK)
2. Boehringer Mannheim / Roche (Switzerland)
Trial website
Publications 1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12953084
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19674936
Contact name Mr  Matthew  Sydes
  Address MRC Clinical Trials Unit
222 Euston Road
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
  Tel +44 (0)207 6704700
  Email matthew.sydes@ctu.mrc.ac.uk
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 06/04/2000
Last edited 12/04/2012
Date ISRCTN assigned 06/04/2000
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.