The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment

Phase 4

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00372372
• Lead Sponsor: Tuen Mun Hospital

Brief Summary

The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment

Detailed Description

We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-06
• Study Completion: 2007-04
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-27
• Last Update Posted: 2007-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (>=0.8mg/kg/day) or equivalent for at least 6 weeks.
2. Age>=18 years and <75 years.

Exclusion Criteria

1. Pregnant or lactating women.
2. Uncorrected hypocalcemia.
3. History of esophageal stricture.
4. Previous intolerance or hypersenstivity to biphosphonates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
bone mineral density

Secondary Outcome Measures

Name	Time	Method
Adverse events, new vertebral fractures

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China