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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372372
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : September 28, 2007
Information provided by:
Tuen Mun Hospital

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: risedronate Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. bone mineral density

Secondary Outcome Measures :
  1. Adverse events, new vertebral fractures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372372

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Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
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Principal Investigator: CC Mok, MD FRCP Tuen Mun Hospital, Hong Kong

Layout table for additonal information Identifier: NCT00372372     History of Changes
Other Study ID Numbers: HARECCTR0500019
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: September 28, 2007
Last Verified: September 2007
Keywords provided by Tuen Mun Hospital:
corticosteroids, bone mineral, risedronate, bisphosphonate
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents