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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.
Information provided by:
Tuen Mun Hospital Identifier:
First received: September 5, 2006
Last updated: September 27, 2007
Last verified: September 2007
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-Blind
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00372372

Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Principal Investigator: CC Mok, MD FRCP Tuen Mun Hospital, Hong Kong
  More Information Identifier: NCT00372372     History of Changes
Other Study ID Numbers: HARECCTR0500019
Study First Received: September 5, 2006
Last Updated: September 27, 2007

Keywords provided by Tuen Mun Hospital:
corticosteroids, bone mineral, risedronate, bisphosphonate

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on July 24, 2017