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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12989577

Enrollment

1300

Registered

2002-02-05

Start date

2001-12-01

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paget's disease Musculoskeletal Diseases Paget's disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Fracture rate	—

Secondary

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

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026