- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372372
The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
September 27, 2007 updated by: Tuen Mun Hospital
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment
Study Overview
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 Type
Interventional
Enrollment
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Tuen Mun Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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bone mineral density
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Secondary Outcome Measures
Outcome Measure |
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Adverse events, new vertebral fractures
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: CC Mok, MD FRCP, Tuen Mun Hospital Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
September 5, 2006
First Submitted That Met QC Criteria
September 5, 2006
First Posted (Estimate)
September 6, 2006
Study Record Updates
Last Update Posted (Estimate)
September 28, 2007
Last Update Submitted That Met QC Criteria
September 27, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Risedronic Acid
Other Study ID Numbers
- HARECCTR0500019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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