Condition category
Musculoskeletal Diseases
Date applied
05/02/2002
Date assigned
05/02/2002
Last edited
12/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/prism.shtml

Contact information

Type

Scientific

Primary contact

Prof SH Ralston

ORCID ID

Contact details

University of Edinburgh
Molecular Medicine Centre
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 651 1037 / 1035
stuart.ralston@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ARC 13627

Study information

Scientific title

Acronym

PRISM

Study hypothesis

Intensive bisphosphonate therapy is superior to symptomatic management in the prevention of long-term complications associated with Paget's disease of bone

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Paget's disease

Intervention

Patients will be randomised to either symptomatic treatment or intensive treatment with a bisphosphonate to maintain serum alkaline phosphatase within the normal range

Intervention type

Drug

Phase

Not Specified

Drug names

Bisphosphonate

Primary outcome measures

Fracture rate

Secondary outcome measures

1. Progression of hearing loss
2. Self-reported health related quality of life
3. Requirement for joint replacement

Overall trial start date

01/12/2001

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1300

Participant exclusion criteria

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

Recruitment start date

01/12/2001

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Edinburgh, Molecular Medicine Centre
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

University of Edinburgh and NHS Lothian (UK)

Sponsor details

Queen's Medical Research Institute
Room E1:06
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9262
marise.bucukoglu@ed.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Arthritis UK (previously Arthritis Research Campaign [ARC]) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aventis & Procter & Gamble (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Association for Relief of Paget's Disease (NARPD) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19580457

Publication citations

  1. Results

    Langston AL, Campbell MK, Fraser WD, MacLennan GS, Selby PL, Ralston SH, , Randomized trial of intensive bisphosphonate treatment versus symptomatic management in Paget's disease of bone., J. Bone Miner. Res., 2010, 25, 1, 20-31, doi: 10.1359/jbmr.090709.

Additional files

Editorial Notes