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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372372
First Posted: September 6, 2006
Last Update Posted: September 28, 2007
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.
Information provided by:
Tuen Mun Hospital
  Purpose
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment

Condition Intervention Phase
Osteoporosis Drug: risedronate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • bone mineral density

Secondary Outcome Measures:
  • Adverse events, new vertebral fractures

Estimated Enrollment: 120
Study Start Date: January 2004
Study Completion Date: April 2007
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
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00372372


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

ClinicalTrials.gov Identifier: NCT00372372     History of Changes
Other Study ID Numbers: HARECCTR0500019
First Submitted: September 5, 2006
First Posted: September 6, 2006
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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs