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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:
Information provided by:
Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00372372
First received: September 5, 2006
Last updated: September 27, 2007
Last verified: September 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00372372     History of Changes
Other Study ID Numbers: HARECCTR0500019
Study First Received: September 5, 2006
Last Updated: September 27, 2007
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013