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

Not Applicable

Completed

• Conditions: Paget's disease; Musculoskeletal Diseases

• Registration Number: ISRCTN12989577
• Lead Sponsor: niversity of Edinburgh and NHS Lothian (UK)

Brief Summary

2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19580457 results 2010 Other publications in https://pubmed.ncbi.nlm.nih.gov/20499339/ Genetic analysis of PRISM participants (added 21/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-02-05
• Study Completion: 2010-12-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1324

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fracture rate

Secondary Outcome Measures

Name	Time	Method
1. Progression of hearing loss<br>2. Self-reported health related quality of life<br>3. Requirement for joint replacement