Multi-centre randomised controlled trial of symptomatic versus intensive bisphosphonate therapy for Paget's disease

ISRCTN	ISRCTN12989577
DOI	https://doi.org/10.1186/ISRCTN12989577
Secondary identifying numbers	ARC 13627

Submission date: 05/02/2002
Registration date: 05/02/2002
Last edited: 21/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof SH Ralston
Scientific

University of Edinburgh, Molecular Medicine Centre
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 651 1037 / 1035
Email	stuart.ralston@ed.ac.uk

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Multi-centre randomised controlled trial of symptomatic versus intensive bisphosphonate therapy for Paget's disease
Study acronym	PRISM
Study objectives	Intensive bisphosphonate therapy is superior to symptomatic management in the prevention of long-term complications associated with Paget's disease of bone
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bisphosphonate
Primary outcome measure	Fracture rate
Secondary outcome measures	1. Progression of hearing loss 2. Self-reported health related quality of life 3. Requirement for joint replacement
Overall study start date	01/12/2001
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1300
Total final enrolment	1324
Key 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.
Key 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
Date of first enrolment	01/12/2001
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Edinburgh, Molecular Medicine Centre

Edinburgh
EH4 2XU
United Kingdom

Sponsor information

University of Edinburgh and NHS Lothian (UK)
Government

Queen's Medical Research Institute
Room E1:06
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Phone	+44 (0)131 242 9262
Email	marise.bucukoglu@ed.ac.uk
"ROR"	https://ror.org/03q82t418

Funders

Funder type

Charity

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

No information available

Aventis & Procter & Gamble (UK)

No information available

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

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No
Other publications	Genetic analysis of PRISM participants	01/11/2010	21/12/2023	Yes	No

Editorial Notes

21/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the main results reference.