Back to resultsThe Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
risedronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring corticosteroids, bone mineral, risedronate, bisphosphonate
Eligibility Criteria
Inclusion Criteria:
- 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.
- Age>=18 years and <75 years.
Exclusion Criteria:
- Pregnant or lactating women.
- Uncorrected hypocalcemia.
- History of esophageal stricture.
- Previous intolerance or hypersenstivity to biphosphonates.
Sites / Locations
- Tuen Mun Hospital
Outcomes
Primary Outcome Measures
bone mineral density
Secondary Outcome Measures
Adverse events, new vertebral fractures
Full Information
NCT ID
NCT00372372
First Posted
September 5, 2006
Last Updated
September 27, 2007
Sponsor
Tuen Mun Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00372372
Brief Title
The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tuen Mun Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
corticosteroids, bone mineral, risedronate, bisphosphonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
risedronate
Primary Outcome Measure Information:
Title
bone mineral density
Secondary Outcome Measure Information:
Title
Adverse events, new vertebral fractures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Age>=18 years and <75 years.
Exclusion Criteria:
Pregnant or lactating women.
Uncorrected hypocalcemia.
History of esophageal stricture.
Previous intolerance or hypersenstivity to biphosphonates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC Mok, MD FRCP
Organizational Affiliation
Tuen Mun Hospital Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
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