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