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ISRCTN
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ISRCTN12989577
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ClinicalTrials.gov identifier
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Public title
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Multi-centre randomised controlled trial of symptomatic versus intensive bisphosphonate therapy for Paget's disease
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Scientific title
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Acronym
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PRISM
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Serial number at source
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ARC 13627
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Study hypothesis
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Intensive bisphosphonate therapy is superior to symptomatic management in the prevention of long-term complications associated with Paget's disease of bone
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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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Randomised controlled 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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Paget's disease
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Participants - inclusion criteria
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The trial will involve patients with Paget's disease over the age of 18 years with symptomatic or asymptomatic disease receiving care at participating hospitals throughout the UK.
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Participants - exclusion criteria
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1. Under 18 years of age
2. Unable to provide written consent
3. Judged by clinician to be too ill or frail to participate
4. Life expectancy of less than one year
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Anticipated start date
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01/12/2001
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Anticipated end date
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31/12/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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1300
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Interventions
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Patients will be randomised to either symptomatic treatment or intensive treatment with a bisphosphonate to maintain serum alkaline phosphatase within the normal range
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Primary outcome measure(s)
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Fracture rate
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Secondary outcome measure(s)
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1. Progression of hearing loss
2. Self-reported health related quality of life
3. Requirement for joint replacement
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Sources of funding
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1. Arthritis Research Campaign (ARC)
2. Aventis & Procter & Gamble
3. National Association for Relief of Paget's Disease (NARPD)
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Trial website
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http://www.abdn.ac.uk/hsru/hta/prism.shtml
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Publications
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Contact name
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Prof
SH
Ralston
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Address
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University of Edinburgh, Molecular Medicine Centre
Western General Hospital
Crewe Road South
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 651 1037 / 1035
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Fax
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+44 (0)131 651 1085
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Email
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stuart.ralston@ed.ac.uk
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Sponsor
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University of Edinburgh and NHS Lothian (UK)
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Address
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Queen's Medical Research Institute
Room E1:06
47 Little France Crescent
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4TJ
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Country
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United Kingdom
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Tel
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+44 (0)131 242 9262
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Fax
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+44 (0)131 242 9301
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Email
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marise.bucukoglu@ed.ac.uk
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Date applied
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05/02/2002
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Last edited
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22/01/2008
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Date ISRCTN assigned
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05/02/2002
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