Multi-centre randomised controlled trial of symptomatic versus intensive bisphosphonate therapy for Paget's disease
| ISRCTN | ISRCTN12989577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12989577 |
| Protocol serial number | ARC 13627 |
| Sponsor | University of Edinburgh and NHS Lothian (UK) |
| Funders | Arthritis UK (previously Arthritis Research Campaign [ARC]) (UK), Aventis & Procter & Gamble (UK), National Association for Relief of Paget's Disease (NARPD) (UK) |
- 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
Contact information
Prof SH Ralston
Scientific
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 |
|---|---|
| stuart.ralston@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bisphosphonate |
| Primary outcome measure(s) |
Fracture rate |
| Key secondary outcome measure(s) |
1. Progression of hearing loss |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
University of Edinburgh, Molecular Medicine Centre
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
